58 finding rules, every one in the open.
This is the rule catalogue EQAWarden runs on every survey, taken from the knowledge file it ships with. Each rule names the statistic it tests, the threshold it uses and who owns that threshold: RCPAQAP, ISO 13528, IUPAC, NIST, Westgard, Bio-Rad, Fraser, or an EQAWarden default the laboratory is asked to ratify. Nothing here is hidden code.
Five principles sit above every rule. RCPAQAP's own assessment is authoritative for inside or outside the APS; EQAWarden recomputes it to check concordance and never re-grades a result. RCPAQAP's words are used on screen. Statistics describe patterns and never establish cause. Every statement carries its numbers and its target source. And an assessment is computed as at its survey, so a signed review can be reproduced later.
Result and target
Every result is scored against its APS and its target's reliability is judged before anything else is read.
-
RES-OUTOutside the APShighRCPAQAP flags a result that is more than the APS from the expected result for review; |D| equal to the APS is within. The APS is evaluated at the target. RCPAQAP's own flag is authoritative; EQAWarden recalculates it to check concordance.
Threshold owner: RCPAQAP -
RES-WARNWithin the APS, in the warning zonelowThe warning zone 2/3 < |A| <= 1 is ISO 13528's 'questionable' band 2 < |z| < 3 with σpt = APS/3. It is not an RCPAQAP flag.
Threshold owner: ISO 13528 -
RES-NOTSCOREDNot scoredinfoCensored results are included in RCPAQAP's statistics with the sign stripped but are not assessed against the APS.
Threshold owner: RCPAQAP -
RES-PROVIDER-DIFFEQAWarden's value differs from RCPAQAP'smediumRCPAQAP's assessment is authoritative. EQAWarden reproduces it to check concordance; a difference beyond rounding usually means a different APS table version, target or unit.
Threshold owner: RCPAQAP -
RES-RED-AMBERRCPAQAP coloured this result red or amberlowRed: outside the APS of the all-result target (and the peer group). Amber: outside one and within the other (introduced about October 2024).
Threshold owner: RCPAQAP -
TGT-SMALLNSmall target grouplowRCPAQAP calculates group statistics only on groups of 6 or more (3 values give a median only, 2 or fewer no statistics); a small group is sensitive to one mis-coded participant and to self-inclusion.
Threshold owner: RCPAQAP -
TGT-UNCTarget uncertainty not negligiblelowu(T) = 1.25 s/sqrt(p). ISO 13528 treats u(T) <= 0.3 σpt as negligible; above 0.7 (about the IUPAC upper bound) EQAWarden does not interpret z at all.
Threshold owner: ISO 13528 9.2; 0.7 band EQAWarden default -
TGT-NONSTDAll-method target for an analyte that is not standardisedlowWithout a reference system, or while routine methods are not yet aligned to one (status partial), methods legitimately differ; an all-method median then mixes method groups. While it holds, the calibration weight of findings that restate a persistent offset is counted for material.commutability (RULES 9).
Threshold owner: EQAWarden knowledge base
Clerical screens
Tested only on results outside the APS, and never altering a result. A blunder contaminates every later statistic, so it is screened first.
-
CLER-SWAPConsistent with a sample swaphighTested only when the targets are far enough apart to tell (|T_B - T_A| > APS(T_A) + APS(T_B)), at least one result is outside the APS and both would be within it once exchanged. log10 LR = 9(Q - Q')/(2 ln 10) under a normal model with σ = APS/3. Never alters a result.
Threshold owner: EQAWarden default -
CLER-SWAP-SURVEYThe same exchange fits several analytes: a specimen swaphighTwo or more swap candidates in one survey, with every other discriminable analyte fitting better exchanged, indicate a specimen swap; a single analyte indicates a result-entry swap.
Threshold owner: EQAWarden default -
CLER-UNITConsistent with a unit errorhighEach factor of the analyte (units.factors; divalent ions also mEq/L; HbA1c by the IFCC-NGSP master equation) is tried in both directions; factors within 10% of 1 are skipped. Candidates are ranked by |A|.
Threshold owner: EQAWarden default -
CLER-DECIMALConsistent with a decimal errorhighPowers of ten from -3 to +3 are tried; a candidate is kept only if it lands within the APS while the reported result does not.
Threshold owner: EQAWarden default -
CLER-DIGITSPossible digit errormediumAdjacent digits are transposed (decimal point fixed) or a digit is dropped or duplicated. At low concentrations such changes can land within the APS by chance, so 'likely' wording needs |A_candidate| <= 0.5.
Threshold owner: EQAWarden default -
CLER-FIELDResult matches another analyte's targetmediumOnly tested when the two targets are more than one APS apart and share the unit.
Threshold owner: EQAWarden default
Survey and cross-analyte
Patterns across the analytes of one survey: one vial shifted, both vials, one instrument, or a set of analytes moving together.
-
YOU-SYSBoth results displaced the same waymediumYouden rotation of the two samples' z_APS: S = (z_A + z_B)/sqrt(2) is the common component; |S| >= 3 is unusual (p about 0.003) under independent normal errors.
Threshold owner: EQAWarden default mirroring the ISO action level -
YOU-RANDResults displaced in opposite directionsmediumR = (z_B - z_A)/sqrt(2) is the differential component; a swap produces a large |R| with the two points mirrored about the target, so the swap test is quoted.
Threshold owner: EQAWarden default mirroring the ISO action level -
SMP-SHIFTCommon shift on one sample: consistent with a reconstitution errorhighInverse-variance pooled log-ratio across the vial's dilution-linear analytes with Cochran's Q for homogeneity; fires when |Z| >= 3, p(Q) > 0.05, at least 5 analytes, |Z| >= 3 still holds with any one analyte left out (the shift does not rest on one analyte), and the other sample does not show it.
Threshold owner: EQAWarden default -
SMP-SHIFT-BOTHCommon shift on both samples of the surveymediumReconstitution affects one vial; a shared analytical cause usually shifts both samples and IQC.
Threshold owner: EQAWarden default -
SMP-INSTRUMENTSeveral analytes shifted on one instrumentmediumFour or more analytes beyond 2/3 of the APS in one direction on one instrument, with a median |A| <= 2/3 for the same analytes elsewhere.
Threshold owner: EQAWarden default -
SIG-GROUPA cross-analyte patternmediumA fault in a shared part of the analyser or the material moves a known set of analytes together in a known direction (for example every enzyme activity with reaction temperature, or sodium, potassium and chloride with the ISE module). The signature library says which analytes, which direction and what the finding supports.
Threshold owner: EQAWarden default
Series and cycle
One analyte on one instrument over time. A single survey cannot separate bias from random error; these rules can, once there are enough surveys.
-
SER-REPEATRepeated results outside the APShighAt least 2 of the last 6 scored results outside the APS, including the current one.
Threshold owner: EQAWarden default -
SER-BIASConsistent bias across surveysmediumMean of the survey summaries zbar_s with a t interval (df m - 1), which does not assume the laboratory's SD equals σpt and absorbs the within-survey correlation. Fires when p < 0.05 and the mean APS score magnitude is at least 0.25.
Threshold owner: Standard test; thresholds EQAWarden default -
SER-RUNA run of results on one side of the targetlowA current run of at least 6 same-sign survey summaries (p = 0.5^(k-1)); also the Westgard-style 10x rule.
Threshold owner: IUPAC/Westgard adapted -
SER-WGA Westgard-style rule signallowRules on z_APS: 2_2z two consecutive beyond 2 on the same side; 4_1z four consecutive beyond 1 on the same side; R_4z within a survey one above +2 and the other below -2. 1_3z is RES-OUT.
Threshold owner: Westgard 1981 definitions; EQA adaptation EQAWarden default -
SER-DRIFTDrift over the cyclemediumMann-Kendall on zbar_s against time (exact for m <= 10) with a Theil-Sen slope. Step and drift are reported side by side and not chosen automatically when m < 10.
Threshold owner: Mann 1945 / Pettitt 1979 -
SER-CUSUMCUSUM signalmediumTwo-sided tabular CUSUM on per-sample z_APS in time order. With h = 5 a false signal within 24 results occurs about 4% of the time; a 1 σpt shift is detected within 12 results about 73% of the time.
Threshold owner: NIST/SPC -
CYC-REGCycle regressioninfoRCPAQAP's method: least squares of results on targets over at least 6 samples with one target source and method category, one pass of atypical exclusion. Deming is primary when target uncertainty attenuates the slope by more than 1%; Passing-Bablok is a robustness check only.
Threshold owner: RCPAQAP -
CYC-MPSMPS above 1.0mediumMPS combines imprecision and bias over the cycle against the APS at the mid-point of the targets; RCPAQAP's summary marks values above 1.0.
Threshold owner: RCPAQAP -
CYC-PROPProportional biasmediumSlope CI excluding 1 and an effect at T_mid of at least a quarter of the APS there.
Threshold owner: effect threshold EQAWarden default -
CYC-CONSTConstant biasmediumIntercept CI excluding 0 and |intercept| at least a quarter of the APS at the lowest target.
Threshold owner: EQAWarden default -
CYC-ATYPICALAtypical result in this cyclelowAtypical: more than 3 S(y.x) and more than the APS from the laboratory's regression line.
Threshold owner: RCPAQAP -
CYC-NONLINCurvature across the rangelowQuadratic term t-test (n - 3 df) and a runs test on residual signs, each at alpha/2 (Bonferroni) so the rule's false-alarm rate stays at alpha; needs at least 8 targets.
Threshold owner: EQAWarden default -
CYC-IMPRECImprecision against the specificationlowThree-state comparison using the one-sided 95% limits of the CV against APS%/2 (RCPAQAP 'APS = 2 x CVa') and, when configured, the biological-variation desirable CV. Fires on 'does not meet'; sigma is never a flag.
Threshold owner: Fraser 1997 -
YOU-CYCLEYouden summary for the cycleinfoOver at least 6 surveys: systematic share, a t test of mean R (constant or non-linear error shows as consistently signed R) and an F test of the run effect.
Threshold owner: EQAWarden default -
SER-OKNo systematic pattern in the surveys so farinfoAbsence of evidence is not evidence of absence, so the bias range the interval still allows is stated.
Threshold owner: EQAWarden default
Lots
Reagent and calibrator lot changes from LotWarden or Unity, each with the confidence of the link.
-
LOT-STEPStep at a reagent or calibrator lot changehighSurvey summaries before and after the change (up to 6 each side, excluding the triggering result when testing persistence); exact permutation p. Fires when p < 0.05 and the step is at least half the APS. With 3 or fewer surveys on a side, a non-significant result is never read as 'no effect'.
Threshold owner: EQAWarden default -
LOT-SHAREDShared shift at a lot change across analyteshighOne calibrator or reagent group serving several analytes, with same-direction LOT-STEP (or IQC steps) in at least 2 of them after its change.
Threshold owner: EQAWarden default -
LOT-RECENTLot changed shortly before analysislowA reagent or calibrator lot change within 14 days before the analysis date.
Threshold owner: EQAWarden default -
LOT-EXPIREDLot past its expirymediumA primary lot on the analysis date was past its expiry date as LotWarden recorded it.
Threshold owner: EQAWarden default -
LOT-CONTROLControl lot changedinfoContext for reading IQC; never evidence for or against an analytical cause by itself.
Threshold owner: EQAWarden default -
LOT-NONENo lot informationinfoA stated limit: LotWarden data or a confirmed analyte map is missing.
Threshold owner: EQAWarden default
Internal QC
Does the laboratory's own control material tell the same story as the EQA sample?
-
IQC-CONCORDANTIQC moved with the EQA resultmediumAt least one level's change has a CI excluding 0 with the sign of D, and |Zc| < 2 at every level with data. Zc compares the IQC change with the EQA deviation in %.
Threshold owner: EQAWarden default -
IQC-STABLEIQC stable while the EQA result deviatedlowEvery level's change CI includes 0 and |Zc| >= 2, on a warning or outside result. A reset IQC target can hide a shift, so the caveat is always shown.
Threshold owner: EQAWarden default -
IQC-STEP-ONLYIQC stepped at the lot change but EQA did notlowQC-material-specific (non-commutable) response to a reagent lot is common.
Threshold owner: Miller 2011 -
IQC-RULESIQC rule violations around the analysis datemediumRCPAQAP's flowchart: check IQC on the EQA run; a run out of control needs action and documentation.
Threshold owner: Bio-Rad Unity / Westgard -
IQC-EVENTA calibration, maintenance or reagent event near the runlowCalibration, maintenance and reagent events shortly before the run are context for the result.
Threshold owner: EQAWarden default -
IQC-PEERUnity peer SDImediumSDI = (laboratory mean - peer mean) / peer SD. Bio-Rad bands: <= 1.25 acceptable, 1.25 to 1.49 acceptable to marginal, 1.5 to 1.99 marginal, >= 2.0 unacceptable. Concordant when the sign matches the series bias and |SDI| >= 1.25.
Threshold owner: Bio-Rad -
IQC-CONFOUNDControl lot changed inside the IQC windowinfoComparing across QC lots confounds the lot's own target with any analytical change.
Threshold owner: EQAWarden default -
IQC-NONENo usable IQCinfoA stated limit.
Threshold owner: EQAWarden default
Method group and knowledge
Your method group from the myQAP report, and the pitfalls the knowledge base knows for the analyte.
-
KNW-PITFALLA known pitfall for this analytelowAn analyte pitfall from the knowledge base whose direction and signature match this result or series.
Threshold owner: EQAWarden knowledge base -
KNW-METHODMethod-dependent analyte compared with a non-method targetlowMethod-dependent analytes are fairly compared only within the method group; RCPAQAP's amber flag is the scheme's own signal.
Threshold owner: EQAWarden knowledge base -
KNW-MATRIXAgrees with the method group, not the all-method medianlowMean A against the category median includes 0 while mean A against the all-method median does not, with a consistent method-group offset. RCPAQAP's flowchart: if the method bias is due to a matrix effect, no further action is required.
Threshold owner: EQAWarden default -
CFG-CORRELATIONA correlation factor is recorded for this assaymediumA correlation (post-analytical correction) factor set in the middleware, LIS or analyser multiplies or offsets every result it reaches, including an EQA result that is not excluded. RCPAQAP states that such factors must not be applied to EQA or QC results. IQC reviewed on the analyser before the factor is applied will not show it.
Threshold owner: The laboratory's analyser configuration -
GRP-LAB-ONLYYour method group reads close to the target; the difference is your laboratory'smediumThe method group median is compared with the assessment target on the same sample. When the laboratory is beyond the warning zone but its method group sits within a third of the APS of the target, the method and the material are unlikely to explain the deviation.
Threshold owner: EQAWarden default -
GRP-SHAREDYour method group reads the same waylowWhen at least half of the laboratory's deviation, in the same direction, is also the method group's deviation from the target, a method or material effect is more likely than a fault in the laboratory. RCPAQAP's flowchart: a method bias due to a matrix effect needs no further action; a method bias that also affects patients is a matter for the manufacturer.
Threshold owner: EQAWarden default -
GRP-POSITIONYour position within your method grouplowz = (result - group median) / group SD, from RCPAQAP's Method Comparison table for the laboratory's own group. |z| 2 to 3 questionable, 3 or more unsatisfactory (ISO 13528). The group SD is the state of the art for the method, not a performance specification; the APS remains the assessment.
Threshold owner: ISO 13528:2022 -
GRP-OFFSETYour method group reads off the specific target, and so do youlowWith a specific (reference) target, the category median is compared with the target on every sample of the series. The rule fires when the group's mean offset is at least a third of the APS with a 95% CI that excludes 0, and the laboratory's mean APS score against its own group's median includes 0.
Threshold owner: EQAWarden default -
GRP-RANKRCPAQAP's ranking of your laboratorylowThe ranking is RCPAQAP's, printed in the survey report's Precision and Accuracy block for the cycle's regression. The bands are from RCPAQAP's legacy end-of-cycle flowchart and are EQAWarden defaults.
Threshold owner: RCPAQAP
Four fixed outcome rules. The first that applies is the suggestion.
The reviewer records the outcome; these rules only propose one, and the basis is shown beside it.
| OUT-CA | Corrective action suggested | First that applies: both samples of the survey outside the APS; SER-REPEAT; SER-BIAS with mean APS score magnitude >= 1 surviving BH; or LOT-STEP with a post-change mean APS score magnitude >= 1. |
|---|---|---|
| OUT-INV | Investigation suggested | Any result outside the APS (RCPAQAP flowchart, NPAAC, ISO 15189:2022 7.3.7.3); CYC-MPS; SER-BIAS >= 0.5; SER-DRIFT or SER-CUSUM with the current mean APS score magnitude >= 0.5; LOT-STEP; or SMP-SHIFT on this analyte's sample. |
| OUT-MON | Acceptable, with monitoring suggested | Any warning-zone result; SER-RUN; SER-WG; SER-BIAS 0.25 to 0.5; CYC-IMPREC; TGT-SMALLN; RES-RED-AMBER. |
| OUT-OK | Acceptable | None of the above. |
Findings support or count against causes. Causes are ranked, never given a probability.
Each finding adds or subtracts points for the causes it bears on: strong 3, moderate 2, weak 1, against 1 or 2. Lot findings are scaled by the confidence of the lot link. A score of 5 or more is strongly supported, 3 to 4 supported, 1 to 2 possible. The ranking orders what to check first.
Clerical
- Transcription error. The result submitted differs from the result the analyser produced: a decimal slip, transposed or dropped digit, or a value entered against the wrong analyte. Transcription is the most frequent cause of EQA results outside the limits in published troubleshooting reviews.
- Unit or conversion error. The result was reported in a different unit from the one RCPAQAP expected (for example mg/dL for mmol/L), or a conversion or LIS factor was applied wrongly. The result then differs from the target by a conversion factor.
- Sample swap. The two samples of a survey were exchanged, either as specimens (tubes, labels or rack positions) or when the results were entered. Both results fall within the APS once exchanged.
Material
- Reconstitution or volume error. The lyophilised vial was made up with the wrong volume, a non-volumetric or uncalibrated pipette, or lost water by evaporation, so every analyte in that vial is shifted by a similar percentage.
- Sample handling or stability. The EQA material changed between reconstitution and analysis for an analyte-specific reason: CO2 loss (bicarbonate), light exposure (bilirubin), enzyme re-activation or loss, glycolysis, contamination or incomplete mixing.
- Matrix effect or method-group difference. The EQA material does not behave like patient samples in your method (non-commutable), or your method group as a whole differs from other methods. Your result agrees with your method group but not with the all-method target. RCPAQAP material is not assumed to be commutable.
Analytical
- Calibration bias or drift. The measuring system is biased or drifting because of its calibration: a proportional (slope) or constant (intercept) error that persists across surveys and is usually seen in IQC as well.
- Reagent lot change. A new reagent lot shifted results. The shift starts at the lot change and persists while the lot is in use.
- Calibrator lot change. A new calibrator lot shifted results, usually proportionally. When one calibrator serves several analytes, a shared shift at its lot change is strong evidence.
- Instrument fault. A fault on one analyser (sample probe, cuvettes, lamp, temperature, electrodes or maintenance) affected several analytes on that instrument at the time of the EQA run.
- Random error or imprecision. A one-off random error (bubble, clot, short sample, carry-over) or a general increase in imprecision. Results scatter without a consistent direction.
- Reaction temperature outside specification. Cuvette or incubation temperature on the analyser differs from 37 C after the last calibration, so catalytic enzyme activities (and, less, rate reactions and immunoassay incubations) are shifted proportionally. Expected signature: all enzymes the same direction on one analyser, CK most, end-point tests unaffected.
- Indirect ISE (IMT) module fault. A fault shared by the Na, K and Cl measurements: sample or diluent volume, IMT Diluent, Standard A or B, Salt Bridge or reference electrode, or ageing of one sensor. Expected signatures: triad same direction (shared dilution or standards), Na and K against Cl (reference), one analyte concentration-dependent (sensor slope).
- Wrong sample volume on the analyser. The analyser took too little or too much sample, or made a predilution incorrectly (short sample, clot, bubble, probe fault, diluent volume, evaporated retained predilution). All results from that aspiration or predilution shift by the same percentage; other modules analysing the same vial do not.
- Contamination of the sample or reaction. Something added to the EQA sample or reaction changes specific analytes: a chelator (EDTA: Ca and Mg low, K high, ALP low), divalent cations (Ca and Mg high), water, ammonia, or a reducing substance. Recognised by a chemically coherent subset of analytes moving while the rest of the vial is unaffected.
- Reagent or sample carry-over. Reagent from one test, or sample from a previous high sample, reaches the next reaction and raises one result in isolation; not reproduced on rerun and dependent on test order. Published pairs include triglyceride reagent into lipase and magnesium reagent contamination.
- Immunoassay separation or signal-generation fault. A fault in the Atellica IM wash (bound and free separation) or in light generation and detection (trigger reagents, label, photomultiplier) after calibration. Signature: sandwich and competitive assays move in opposite directions (signal loss: sandwich low, competitive high; incomplete washing: sandwich high, competitive low).
Target
- Uncertain or unsuitable target. The expected result itself is uncertain: a small peer group, wide group spread, a target source that changed, or an all-method target for an analyte that is not standardised.
None
- Chance variation. A result in the warning zone or near the limit with no other pattern. For a laboratory performing exactly at sigma_pt, about 1 result in 20 falls in the warning zone by chance.
Result path
- Post-analytical correction (correlation) factor applied to EQA results. A slope or offset configured in the analyser, CentraLink or LIS altered the EQA result. RCPAQAP requires that such factors are never applied to EQA or QC results. Signature: one analyte, constant ratio or offset from a dated step, IQC unaffected where the factor is applied in CentraLink or the LIS, but IQC carries it too where the factor sits in the analyser's test definition.
- Result mapping, unit or rounding error in the middleware or LIS. The value reported came from the wrong test definition, the wrong unit, a wrong calculation rule or a rounding or truncation rule. Signature: agreement with another method group or another unit factor, or a small constant offset, starting at a configuration change.
See a rule fire on real-looking data.
The walkthrough opens the fictional demo year, where a reagent lot step, a sample swap, a unit error and a reconstitution error are all waiting to be found.