NetworkLabSampleRoutingChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of NetworkLabSampleRoutingChecker for Network Lab Sample Routing Checker.

Domain limits and critical parameters

• Comprehensive routing validation per CAP/CLIA, ISO 15189, GDP and GLP/GCP: destination site capabilities (test availability, sample type acceptance, accreditation scope, capacity), logistics constraints (transit time vs sample stability, temperature control compliance), documentation & compliance (MTA execution, export licenses, customs documentation, informed consent for transfer, chain of custody), SLA compatibility (active agreement, STAT priority alignment), and cross-border requirements. Th
• ⚠️ Critical: Missing accreditation for test = INVALID clinical result. Transit exceeding stability = sample degradation = false results. MTA mandatory for inter-entity transfers. Cross-border without customs docs = border hold + TAT violation. STAT without expedited SLA = guaranteed delay. Route verification is COMPLEMENTARY to, not replacement for, sample pre-analytical QC.

URS — User Requirements Specification

input.csv contract

SampleID,PatientID,OrderedTest,Priority,SampleType,OriginSite,DestinationSite,AlternateSite,DestinationSite_TestAvailable,DestinationSite_SampleTypeAccepted,DestinationSite_CapacityAvailable,DestinationSite_AccreditedForTest,EstimatedTransit_Hours,MaxAllowableTransit_Hours,TemperatureControl_Available,RequiredTempCondition_Met,TransportMethod,MTA_Required,MTA_Executed,ExportLicense_Required,ExportLicense_Valid,ChainOfCustody_Complete,InformedConsent_TransferOK,SLA_Active,SLA_TAT_Hours,PriorityCompatible_WithSLA,IsCrossBorder,OriginCountry,DestinationCountry,CustomsDocumentation_Complete
ROUTE-2026-001,PAT-042,NSCLC_CGP_Panel,STAT,FFPE,Hospital_A,RefLab_Central,RefLab_East,true,true,true,true,4,24,true,true,Courier,false,false,false,false,true,true,true,120,true,false,US,US,false
ROUTE-2026-002,PAT-055,WES_Germline,Routine,Whole_Blood,Clinic_B,RegionalLab_West,RefLab_Central,false,true,true,false,36,24,true,true,Mail,true,false,false,false,true,true,true,168,true,false,US,US,false
ROUTE-2026-003,PAT-061,MRD_Personalized,Routine,Plasma,Hospital_DE,RefLab_US,RefLab_UK,true,true,true,true,18,48,true,true,Courier,true,true,true,true,true,true,true,168,true,true,DE,US,true

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "networklabsampleroutingchecker",
  "utilityFolder": "NetworkLabSampleRoutingChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "ROUTE-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "PatientID",
      "value": "PAT-042",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "OrderedTest",
      "value": "NSCLC_CGP_Panel",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "Priority",
      "value": "STAT",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "SampleType",
      "value": "FFPE",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "OriginSite",
      "value": "Hospital_A",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "DestinationSite",
      "value": "RefLab_Central",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "AlternateSite",
      "value": "RefLab_East",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "DestinationSite_TestAvailable",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "DestinationSite_SampleTypeAccepted",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "DestinationSite_CapacityAvailable",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "DestinationSite_AccreditedForTest",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "NetworkLabSampleRoutingChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.