Clinical Laboratory Diagnostics

AssayCore Med

AssayCore Med is built for clinical diagnostic laboratories that process thousands of samples daily. The system covers every step from order creation through result delivery, with built-in QC (Westgard rules, Levey-Jennings), bidirectional instrument connectivity via HL7v2 and ASTM E1394, and FHIR R4 export for HIS/EMR integration. Delta check, critical value alerts with escalation, and TAT monitoring are all natively supported.

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Compliance & Standards

ISO 15189:2022ISO/IEC 17025:2017FDA 21 CFR Part 11CLIA (42 CFR 493)CAP Laboratory AccreditationHL7v2HL7 FHIR R4ASTM E1394Westgard QCIFCC reference intervalsGDPRHIPAA-ready

Platform Modules

Complete feature set covering every stage of your laboratory workflow.

Patient & Order Management

Patient registration with full demographic and insurance data
Order templates and test complexes (panels)
CITO / STAT priority flags with worklist highlighting
Pre-billing preview per order
Repeat order from previous visit

Sample Lifecycle

Code128 and DataMatrix barcode generation per tube
Aliquoting and split/merge operations
Routing to workstations by test type
Defect catalog with photo evidence and cancel/restore
Temperature and transport log

Results & Verification

Manual and batch result entry
Auto-verification with rule engine
Result history trend charts
Delta check (absolute and percentage) per analyte
Critical value confirmation with read-back dialog

Quality Control

All 13 Westgard rules (including R4s, 10x, 2of3-2s)
Levey-Jennings charts with exclude-point annotation
QC Convergence (new lot validation)
QC Establishment (mean/SD setup period)
Control material reference (Bio-Rad, Randox)

Instrument Integration

HL7v2 bidirectional connectivity
ASTM E1394 analyzer protocol
Worklists export to instruments
FHIR R4 Observation and DiagnosticReport
Real-time result import with mapping rules

Reporting & Compliance

PDF reports via Thymeleaf with QR verification code
Excel batch export with Apache POI
Full audit trail (21 CFR Part 11 e-signature ready)
TAT monitoring dashboard with SLA alerts
ISO 15189 accreditation support

Who Uses AssayCore Med?

Hospital central labs processing 1,000–10,000 samples per day
Outpatient diagnostic networks (chain labs) with multi-site reporting
Reference laboratories with high-complexity testing
Clinics requiring HIS/EMR integration via FHIR

Integrations

HL7v2ASTM E1394FHIR R4Roche cobasSysmex XNSiemens AtellicaBeckman DxHKeycloak SSOKafkaMinIO

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