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Production stack for AssayCore Med
Core: PostgreSQL 16 + Redis 7 + Kafka 3.7 + MinIO + Keycloak 24 + Spring Boot 3.3 (Kotlin) + React 18/MUI + FastAPI ML (Python 3.11) + Nginx + Docker
Module-specific: HL7 v2.5.1 (HAPI HL7v2) · FHIR R4 (HAPI FHIR) · ASTM E1394 analyzer bridge · LOINC auto-mapping · Westgard 13-rule QC engine · HIPAA on-prem playbook (pgcrypto + AD/LDAP via Keycloak)
Deployable on your infrastructure or our managed Hetzner. Self-hosted source-license available.
Reagent Lot-Release QC
Multi-rule evaluation · Westgard Basic QC Practices 5th ed · CLSI EP05-A3 · CAP QC-Pearl
Lots pending release
2
Released
7
Rejected
7
Active QC rules triggered
8
Westgard rules: 1-3s = 1 control > ±3 SD (warning); 2-2s = 2 consecutive > ±2 SD; R-4s = range > 4 SD (reject); 4-1s = 4 consecutive on same side; 10x = 10 consecutive same side. Source: Westgard Basic QC Practices 5th ed, pp.145–162.
| Reagent Kit | Lot | QC Material | Acceptance Range | Observed mean ± SD | Westgard Rule | Received | Status |
|---|---|---|---|---|---|---|---|
Glucose HK R1/R2 Roche | LOT-RO-958612 | Bio-Rad Lyphochek Chem L1 | 4.8 – 5.8 | 4.71 ± 0.04 | R-4s | 2026-06-05 | Rejected |
Creatinine Jaffé R1/R2 Roche | LOT-RO-136702 | Bio-Rad Lyphochek Chem L2 | 85 – 105 | — | 4-1s | 2026-06-11 | Pending |
ALT (IFCC) Reagent Roche | LOT-RO-124128 | Randox Assayed Chem L1 | 32 – 46 | 47.64 ± 0.97 | R-4s | 2026-06-10 | Rejected |
AST (IFCC) Reagent Roche | LOT-RO-198551 | Randox Assayed Chem L2 | 28 – 40 | — | None | 2026-06-12 | Pending |
Total Protein Biuret Roche | LOT-RO-136806 | Stanbio Chemistry Ctrl L1 | 58 – 74 | 69.92 ± 1.07 | None | 2026-06-13 | Released |
HbA1c Cartridge Abbott | LOT-AB-653014 | Bio-Rad LYPHOCHECK Diabetes L1 | 47 – 59 | 48.22 ± 0.27 | None | 2026-06-13 | Released |
Troponin I STAT Abbott | LOT-AB-445719 | Randox Cardiac Ctrl L2 | 0.028 – 0.05 | 0.049 ± 0 | None | 2026-06-13 | Released |
TSH 3rd Gen Siemens Healthineers | LOT-SI-875489 | Bio-Rad Lyphochek Immunoassay L1 | 0.85 – 1.55 | 1.54 ± 0.05 | None | 2026-06-08 | Released |
Free T4 (FT4) Siemens Healthineers | LOT-SI-408953 | Bio-Rad Lyphochek Immunoassay L2 | 9.8 – 16.2 | 17.08 ± 0.44 | R-4s | 2026-06-07 | Rejected |
PSA Total Beckman Coulter | LOT-BE-555337 | Randox PSA Ctrl L1 | 3.2 – 5.8 | 4.61 ± 0.18 | None | 2026-06-14 | Released |
PT (NeoPTimal) Stago | LOT-ST-570318 | Stago CK Prest L2 | 10.5 – 13.5 | 11.6 ± 0.08 | None | 2026-06-06 | Released |
aPTT Liquid Stago | LOT-ST-906890 | Stago CK Prest L1 | 28 – 38 | 39.21 ± 0.44 | 1-3s | 2026-06-08 | Rejected |
D-Dimer STA-Liatest Stago | LOT-ST-601315 | Stago CK-STA L2 | 0.35 – 0.65 | 0.68 ± 0.02 | 2-2s | 2026-06-15 | Rejected |
HbA1c VARIANT II Turbo Kit Bio-Rad | LOT-BI-526945 | Bio-Rad LYPHOCHECK Diabetes L2 | 70 – 88 | 68.39 ± 1.43 | 1-3s | 2026-06-15 | Rejected |
Urinalysis KOVA Stain Iris Diagnostics | LOT-IR-774054 | Stanbio Urinalysis Ctrl | 4.2 – 5.8 | 5.88 ± 0.05 | 2-2s | 2026-06-10 | Rejected |
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