CLIA · CAP · 21 CFR Part 11 · HIPAA · HL7 FHIR

Track every sample.
Every step.

Desktop LIMS for molecular diagnostics. 42 pages of lab intelligence — from kit creation to EHR export. Machine-locked. Audit-ready. Compliant.

Request Demo → See Features ↓
42+
Pages
17
Compliance Rules
19
Database Tables
5
RBAC Roles
3
Instrument Parsers
10
Step Workflow
Core Capabilities

Built for Molecular Diagnostics

Every feature purpose-built for CLIA/CAP regulated molecular labs. Zero filler.

📦

Kit Lifecycle

5 pages · 9 kit states
  • Generate kits with QR codes
  • Track through 9 states
  • Print to Zebra, DYMO, Brother
  • Carrier tracking integration
🔍

Scan-to-Receive

USB barcode scanners
  • Scan barcode → patient auto-identified
  • Verify specimen condition
  • Automatic accessioning
  • Chain of custody tracked
📋

Processing Kanban

Automation ready
  • Scan-to-advance workflow board
  • STAT samples pulse with priority
  • Chain of custody at every step
  • Batch processing support
🧪

Instrument Import

3 parsers
  • QuantStudio data import
  • Bio-Rad CFX data import
  • Generic CSV import
  • Auto-match samples, interpret Ct
🧬

Worklists

3 formats
  • 96-well plate layouts
  • 384-well plate layouts
  • OpenArray (3,072 wells)
  • Controls, replicates, fill order
✅

e-Signatures & QC

21 CFR Part 11 compliant
  • PIN-based e-signatures
  • Batch approve 50+ results
  • Levey-Jennings ±2SD/±3SD
  • Westgard 1-2s warning, 1-3s rejection
🔗

HL7 / FHIR Integration

EHR ready
  • FHIR R4 DiagnosticReport
  • HL7 v2.5.1 ORU^R01
  • Epic / Cerner compatible
  • Patient import from EHR
🔒

Machine Lock

Anti-piracy secured
  • SHA-256 hardware fingerprint
  • License → register → bind
  • 5 RBAC roles
  • PHI encryption (HIPAA)
📊

Reporting & Billing

End-to-end
  • PDF reports with letterhead
  • CPT code billing integration
  • TAT monitoring (CLIA §493.1291)
  • Competency & proficiency tracking
End-to-End

10-Step Sample Workflow

Order to report — fully tracked and audited at every step.

📝
1
Order
→
📋
2
Assign
→
🚚
3
Ship
→
🩸
4
Collect
→
🔍
5
Receive
→
⚙️
6
Process
→
📊
7
Result
→
✅
8
Approve
→
📄
9
Report
→
🔗
10
Export
Regulatory

17 Compliance Rules — All Implemented

Not aspirational. Every regulation cited below is actually enforced in the software.

🏥 CLIA
Clinical Laboratory Improvement Amendments
  • CLIA §493.801 — Proficiency Testing
  • CLIA §493.1251 — Quality Control
  • CLIA §493.1451 — Competency Assessment
  • CLIA §493.1291 — TAT Monitoring
🏆 CAP
College of American Pathologists
  • CAP GEN.20316 — Reagent Lot Tracking
  • CAP GEN.40491 — Temperature Monitoring
  • CAP COM.30450 — Maintenance Scheduling
  • CAP ANP.12200 — Chain of Custody
  • CAP GEN.20377 — Document Control
  • CAP CHM.06500 — Specimen Integrity
📜 21 CFR Part 11
FDA Electronic Records & Signatures
  • §11.10(e) — Electronic Signatures
  • §11.10(e) — Immutable Audit Trail
  • §11.10(d) — Access Controls
  • PIN-based signature authentication
🛡️ HIPAA & HL7
Privacy & Interoperability Standards
  • HIPAA §164.312 — PHI Encryption
  • HL7 FHIR R4 — DiagnosticReport
  • HL7 v2.5.1 — ORU^R01 Messages
  • Epic / Cerner EHR compatible
Product Preview

42+ Pages of Lab Intelligence

Every page purpose-built. Zero filler.

📊
Dashboard

KPIs, sample pipeline, STAT queue, trend analytics

📋
Processing Board

Kanban workflow with scan-to-advance progression

🔍
Receiving

Scan barcode → patient auto-identified → accession

📈
QC Charts

Levey-Jennings plots with Westgard rules enforcement

🧬
Worklists

96-well, 384-well, and OpenArray plate layouts

✅
Batch Approval

50+ results signed with a single e-signature PIN

Pricing

Simple, Transparent Pricing

No per-test fees. No surprises. Flat subscription or perpetual license.

Starter
$299 /mo
$2,999/yr · $9,999 perpetual
1 tenant / 5 users
1,000 kits per month
Kit management + QR codes
Sample receiving
Basic QC
96-well worklists
No HL7/FHIR integration
No batch approval
Get Started →
Professional
$799 /mo
$7,999/yr · $29,999 perpetual
3 tenants / 25 users
10,000 kits per month
Everything in Starter
Full Westgard QC rules
HL7 FHIR R4 integration
Batch approval (50+)
384-well worklists
Billing / CPT codes
Competency + PT tracking
Temperature monitoring
Get Started →
Enterprise
$2,499 /mo
$24,999/yr · $79,999 perpetual
Unlimited tenants & users
Unlimited kits
Everything in Professional
OpenArray (3,072 wells)
Custom reports
Validation (IQ/OQ/PQ)
4-hour SLA support
API access
Source code escrow
On-premise deployment
Contact Sales →

All plans include updates. Perpetual license available for all tiers. No per-test fees.

Security

Machine-Locked & Audit-Ready

🔒
Machine Lock

SHA-256 hardware fingerprint. License, register, bind. Anti-piracy protection.

🛡️
Role-Based Access

5 RBAC roles with granular permissions. PHI encryption for all patient data.

📝
Immutable Audit Trail

Every action logged. Every signature verified. Complete chain of custody from kit to report.

Ready to Modernize Your Lab?

Request a demo and see how LabTrackr transforms your molecular diagnostics workflow.

Request Demo → Back to omeletteinc.com