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PQ Protocol — TransTrack Performance Qualification (Worked Example)

⚠ DEMONSTRATION ONLY — NOT A REAL VALIDATION RECORD

"Northshore Regional Transplant Center" is a fictional organization. All test results, throughput numbers, and signatures below are synthetic demonstration data. See README.md. Real pilot sites should execute against the empty template at ../templates/PQ_PROTOCOL_TEMPLATE.md.

Document control
Document ID TT-PQ-NRTC-001 (example)
Software version v1.2.0 (build e1436e2)
Executed by Sarah Chen, RN — Validation Lead + Coordinators K. Adeyemi & L. Hernandez (role-title placeholders)
Reviewed by Marcus Johnson, MS — QA Officer (role-title placeholder)
Date executed 2026-06-25 (example)

Purpose

Verify TransTrack v1.2.0 performs as intended in NRTC's actual clinical-coordination workflow with representative volumes and representative users. PQ executed in the non-PHI test environment populated with synthetic patients approximating the live workload.

Pre-conditions

  • IQ (IQ_PROTOCOL_EXAMPLE.md) and OQ (OQ_PROTOCOL_EXAMPLE.md) executed and PASS.
  • Test environment loaded with 1 042 synthetic patients:
    • 612 kidney
    • 198 liver
    • 92 lung
    • 78 heart
    • 62 pancreas
  • Three representative end users available:
    • 1 admin (Sarah Chen, RN)
    • 1 coordinator (K. Adeyemi)
    • 1 viewer (Dr. R. Whitfield)

Workflow scenarios (executed)

ID Scenario Acceptance Pass/Fail Notes
PQ-01 Admit a new patient end-to-end (intake → barriers → labs → AHHQ → priority score). <5 min, no errors. PASS 4 m 12 s end-to-end (synthetic patient MRN-NRTC-PQ-001); no errors.
PQ-02 Receive a sample HL7 v2 ADT^A01 message and confirm patient appears within 60 seconds. <60 s. PASS Patient appeared 3 s after MLLP send; MRN+DOB matching worked.
PQ-03 Coordinator opens patient list. First page renders ≤2 s for 1 000+ patients. PASS First-page render 0.84 s (1 042 patients, 50/page).
PQ-04 Coordinator handles a simulated organ offer cycle (offer → accept). Audit row + state transition correct. PASS Transition PENDING→ACCEPTED_PROVISIONAL→ACCEPTED_FINAL audited.
PQ-05 Coordinator handles a simulated decline with reason code. Reason recorded; backup recipient notified. PASS Decline reason MEDICAL_CONDITION_INCOMPATIBLE recorded; in-app notification raised to next match candidate.
PQ-06 Post-transplant: record transplant event, immunosuppression regimen, follow-up labs. All recorded; tasks generated. PASS 3 events, 1 immuno regimen, 4 labs, 2 follow-up tasks generated.
PQ-07 Living-donor evaluation: complete each step; verify 6/12/24-month follow-up tasks. Tasks generated at correct intervals. PASS Tasks generated at exactly +6, +12, +24 months from transplant date.
PQ-08 Generate monthly admin audit report scoped to one coordinator. Report opens ≤10 s; contains expected rows. PASS 30-day audit report for K. Adeyemi: 1 423 rows, render 4.2 s.
PQ-09 Backup, then simulate disaster: restore on a second host. Restore completes ≤30 min for 100 000 records; data integrity preserved. PASS 3 successful backup→verify→restore cycles on a second NRTC workstation (NRTC-TX-WS02); restore for 1 042-patient dataset completed in 1 m 46 s; row count and integrity hash matched.
PQ-10 SIEM forwarder destination outage: events queued and replayed when destination returns. No event loss within queue capacity. PASS Simulated 10-min siem.nrtc.local outage: 87 events queued; on recovery, all 87 replayed in CEF.
PQ-11 Run end-to-end smoke for 4 hours under coordinator user load. No memory leaks; no untrapped errors. PASS 4 h 02 min synthetic workload by 2 coordinators; renderer process RSS stayed at 312 MB → 318 MB (no leak); 0 untrapped errors in transtrack.log.
PQ-12 Validate "operational not allocative" labels visible on every score-bearing screen. All present. PASS All 6 score-bearing screens (Dashboard, Patient Detail, Priority Breakdown, Risk Engine, Match Simulator, OPTN Export) carry the disclaimer.

Acceptance

  • All Mandatory PQ scenarios PASS.
  • Performance targets met (TT-R080 to TT-R083 of docs/compliance/SYSTEM_REQUIREMENTS_SPECIFICATION.md).
  • No Severity 1 or 2 defects open.

Result: 12/12 PASS. PQ accepted.

Role Name (placeholder) Signature Date
Executor Sarah Chen, RN + K. Adeyemi + L. Hernandez signed 2026-06-25
QA Reviewer Marcus Johnson, MS signed 2026-06-29
Transplant Administrator Dr. R. Whitfield signed 2026-06-30

End-of-document reminder: the patient counts, throughput numbers, signatures, and host identifiers above are demonstration data.