SampleTransportStabilityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of SampleTransportStabilityChecker for Sample Transport Stability Checker.

Domain limits and critical parameters

• Performs transport condition verification per CLSI GP44-A2, CAP/CLIA §GEN.48800, ISO 15189 §7.3.3, IATA Temperature Control Regulations and GDP: transit duration vs validated maximum, IoT temperature logger presence/functionality/data completeness, temperature excursion tracking (count, total/max duration, extreme values), stabilizer validation for transport conditions, packaging appropriateness (insulation, orientation, vibration protection), physical integrity at receipt (container damage, lea
• ⚠️ Critical: Transport is the most vulnerable pre-analytical stage; errors here are irreversible. Missing logger ≠ "presumably OK"; this is MONITORING_GAP or REJECTED. Even brief RNA excursion can cause significant degradation. Leakage = dual problem: sample loss + biohazard. Dry ice must remain until receipt; complete evaporation = rejection. Transport stability validation must be performed FOR EACH matrix/stabilizer/packaging/season combination. IoT loggers must be calibrated; expired calibrat
• • CAP/ISO accreditation: Documentation of pre-analytical transport management.

URS — User Requirements Specification

input.csv contract

SampleID,PatientID,SampleType,AnalyteTarget,AssayName,OriginSite,DestinationLab,ShipDateTime_Utc,ReceiveDateTime_Utc,TransitDuration_Hours,MaxValidatedTransit_Hours,TransportMode,TempLogger_Present,TempLogger_Functional,Temp_Min_Recorded_C,Temp_Max_Recorded_C,Temp_Mean_Recorded_C,RequiredTempRange_C,RequiredTemp_Min_C,RequiredTemp_Max_C,TempWithinRange_EntireTransit,ExcursionCount,TotalExcursionDuration_Hours,MaxSingleExcursion_Hours,MaxAllowedExcursion_Hours,MaxAllowedSingleExcursion_Hours,ExcursionMaxTemp_C,ExcursionMinTemp_C,StabilizerUsed,Stabilizer_ValidatedForTransport,PackagingType,Packaging_AppropriateForTemp,TubeOrientation_Correct,VibrationProtection_Adequate,ContainerIntact_AtReceipt,Leakage_Detected,Hemolysis_VisualCheck,Clotting_Detected,DryIce_Remaining,FillVolume_Percent,StabilityData_ForTransportConditions,ValidationReference
TRSP-2026-001,PAT-LUNG-042,cfDNA_Streck,cfDNA,NSCLC_CGP,City Hospital,RefLab Central,2026-06-07T08:00:00,2026-06-07T20:00:00,12,72,Courier,true,true,18.5,24.2,21.0,15-30,15,30,true,0,0,0,4,2,0,0,Streck,true,Ambient_Envelope,true,true,true,true,false,false,false,false,95,true,IFU-Streck-v3.2
TRSP-2026-002,PAT-CRC-055,Whole_Blood,RNA,Immune_Profiling,Regional Clinic,RefLab Central,2026-06-06T14:00:00,2026-06-07T18:00:00,28,24,Courier,true,true,3.8,9.5,6.2,2-8,2,8,false,2,3.5,2.1,2,1,9.5,3.8,PAXgene,true,Insulated_Box,true,true,true,true,false,false,false,false,90,true,SOP-TRANSPORT-RNA-001
TRSP-2026-003,PAT-BRCA-061,Fresh_Tissue,RNA,WTS_Panel,Surgery Dept,Molecular Lab,2026-06-05T10:00:00,2026-06-06T22:00:00,36,4,Internal,false,false,0,0,0,-80±10,-90,-70,false,0,0,0,0.5,0.5,0,0,RNAlater,false,Dry_Ice_Shipper,false,false,false,false,true,false,false,false,60,false,

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "sampletransportstabilitychecker",
  "utilityFolder": "SampleTransportStabilityChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "TRSP-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "PatientID",
      "value": "PAT-LUNG-042",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "SampleType",
      "value": "cfDNA_Streck",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "AnalyteTarget",
      "value": "cfDNA",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "AssayName",
      "value": "NSCLC_CGP",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "OriginSite",
      "value": "City Hospital",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "DestinationLab",
      "value": "RefLab Central",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "ShipDateTime_Utc",
      "value": "2026-06-07T08:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "ReceiveDateTime_Utc",
      "value": "2026-06-07T20:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "TransitDuration_Hours",
      "value": "12",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "MaxValidatedTransit_Hours",
      "value": "72",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "TransportMode",
      "value": "Courier",
      "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": "SampleTransportStabilityChecker.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.