Internal QC · Levey–Jennings
ISO 15189:2022 §7.3.7 · Westgard multirule · QC failures lock patient results for the run
Mean 3.20 · SD 0.10 mg/dL (lab-established, n=20)
RUN R-1013-04 LOCKED · 2-2s rule violated (systematic error)
Two consecutive L2 controls above +2 SD (3.43, 3.46 mg/dL). 38 patient results held — no release, no autoverification. Record corrective action, rerun QC, then release.
Creatinine · Level 2 · last 20 runs
±1 SD±2 SD±3 SD
Westgard rules
2 control levels1-2sOne control beyond ±2 SDWarning1-3sOne control beyond ±3 SD — random errorReject2-2sTwo consecutive beyond same ±2 SD — systematicRejectR-4sRange between levels > 4 SD — randomReject4-1sFour consecutive beyond same ±1 SDReject10xTen consecutive on one side of meanRejectWith 3 levels MedX switches to 2of3-2s, 3-1s and 6x automatically.
Sigma metric · Creatinine
4.6 σ
Monthly CV% (Sep)
2.8%
QC runs today
46
Violation log
every rejection needs corrective action before release| Date | Analyzer · test · level | Rule | Results held | Corrective action | By | Status |
|---|---|---|---|---|---|---|
| 13 Oct 10:42 | BS-480 · Creatinine · L2 | 2-2s | 38 | — pending — | Usman Ghani | Run locked |
| 13 Oct 09:15 | Maglumi 800 · TSH · L1 | 1-2s | 0 | Warning only · watch next run | Areeba Shah | Monitoring |
| 07 Oct 11:03 | BS-480 · Creatinine · L2 | 1-3s | 22 | Cuvette wash, new control vial, rerun pass · 22 results re-released | Usman Ghani | Closed · Dr. Kamran |
| 02 Oct 08:50 | XN-550 · PLT · L3 | R-4s | 17 | Probe blockage cleared, re-calibrated | Bilal Hussain | Closed |
External quality assessment (EQA)
RIQAS · Bio-Rad EQAS · AFIP| Scheme · cycle | Analyte | Our result | Peer mean | SDI | Outcome |
|---|---|---|---|---|---|
| RIQAS Chem · C24 S7 | Glucose | 142 | 139.8 | 0.4 | Pass |
| RIQAS Chem · C24 S7 | Creatinine | 2.31 | 2.12 | 2.2 | Investigate · NC-0411 |
| Bio-Rad Immuno · S3 | TSH | 4.82 | 4.70 | 0.6 | Pass |
| AFIP Haem · 2026-3 | Hb | 11.6 | 11.5 | 0.3 | Pass |
Reagent lots · lot-to-lot (CLSI EP26)
| Reagent | Lot | Expiry | Opened | EP26 check |
|---|---|---|---|---|
| Creatinine (enzymatic) | CR2609A | Feb 2027 | 01 Oct · 28 d stable | In use · passed |
| Creatinine (enzymatic) | CR2610C | Apr 2027 | — | Verifying · 6/10 samples |
| TSH (CLIA) | TS26118 | Jan 2027 | 05 Oct | In use · passed |
| HbA1c buffer kit | D10-4471 | Nov 2026 | 20 Sep | Expires in 18 d · reorder |
Calibration & maintenance due
Assets & biomed →Overdue
BS-480 · Creatinine calibration (lot change CR2610C)
due 12 OctToday
XN-550 · daily shutdown & clean · background check
by 20:00This week
Maglumi 800 · weekly maintenance · probe wash
16 OctMonthly
Lab fridge F-02 · thermometer calibration (2–8 °C)
31 Oct