Four requirement families, four delivery phases
R1–R4 define what must be true; P1–P4 define the order it becomes true. Each phase ends with a demonstrable hero flow on the deployed system.
Requirement families
| Family | Scope | Non-negotiables |
|---|---|---|
| R1 · Security & compliance | HIPAA, CLIA, CAP/COLA readiness | US hosting under BAA · immutable audit on every PHI access · released results immutable (corrected versions) · critical-value closed loop · retention ≥ 2 yr · schema-per-tenant isolation |
| R2 · Core lab workflow | Compendium → order → accession → result → verify → report | LOINC-coded catalog with reflex rules · scanner-first accessioning < 5 s · state machine server-side · QC-gated release · STAT elevation everywhere |
| R3 · Connectivity | Instruments, EHRs, reference labs, public health | Separate interface-engine process · HL7 v2 over MLLP · ASTM drivers · no inbound message ever dropped · FHIR R4 + ELR later · PDF/fax first-class |
| R4 · Business layer | RCM, portals, onboarding | Eligibility + medical necessity at order time · clean-claim events behind a BillingProvider adapter · denial analytics · physician/patient/DTC portals · POL self-serve < 1 day |
Delivery phases
P1
Foundation & core loop
One lab runs a real bench day — manually.
- Cloud stack, CI/CD, tenant provisioning & signup
- Auth, lab-role RBAC, immutable audit
- LOINC starter compendium, order entry, barcode labels
- Scanner-first accessioning, manual results, verification state machine
- Report PDF v1, worklists
HERO FLOWorder → labels → accession → result → verify → PDF report
P2
Connectivity & quality
Instruments and clients connect; quality machinery online.
- Interface engine: HL7 + ASTM, two real analyzers, message log & replay
- Physician portal: online ordering, results inbox, critical notifications
- QC (Levey-Jennings, Westgard, release gating), auto-verification v1, delta checks
- Critical-value closed loop, rejection & storage, send-outs v1
HERO FLOWanalyzer files result → auto-verify releases → portal in < 30 s
P3
Business layer
The lab gets paid through the product.
- CPT/ICD coding, eligibility, necessity checks
- Claims via clearinghouse adapter, denial worklist & analytics
- Patient portal GA + DTC portal with online payment
- Mobile collection & courier chain of custody
- Multi-site, subscription billing, operator console
HERO FLOWportal order → field draw with custody scans → clean claim paid
P4
Specialty & moat
Win specialty labs; out-modernize incumbents.
- Toxicology (rx-vs-detected), microbiology, molecular basics, AP hooks
- FHIR R4 GA + SMART-on-FHIR, ELR feeds, EHR marketplace connectors
- AI assist (advisory): rule tuning, anomaly detection, requisition OCR
- CAP/COLA inspection-readiness pack
- Lab-to-lab send-out network
HERO FLOWtox result auto-flags rx inconsistency → pathologist reviews with AI brief
Phase exit gates:
threat model closed→
green CI→
zero-mock sweep→
hero flow human-verified on the deployed stack
Reuse advantage
Development does not start from zero: an existing in-house healthcare platform (FastAPI + Next.js, with production auth/RBAC/MFA, audit logging, PDF report generation, and lab catalog/reflex-rule models) provides directly adaptable code, and two further in-house products contribute proven patterns for HL7 partner interoperability, specimen chain-of-custody with offline idempotency, accession numbering, barcode document generation, PHI field encryption, and subscription billing. This materially de-risks P1–P3 timelines.