SampleAgeAndStabilityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of SampleAgeAndStabilityChecker for Sample Age & Stability Checker.

Domain limits and critical parameters

• Performs sample suitability verification per CLSI EP28-A3c, CAP/CLIA §GEN.48800, ISO 15189 §7.3.3 and IVD manufacturer instructions: stability time windows (time-to-processing, post-processing age vs validated maximum, total age, remaining stability %), storage conditions (temperature compliance, cold chain, excursion duration vs allowed), freeze-thaw cycles (count ≤ max), stabilizer-assay compatibility, container appropriateness, integrity scores (DIN ≥2.0 for DNA, RIN ≥5.0 for RNA, DV200 ≥30%,
• ⚠️ Critical: Sample degradation does NOT cause explicit QC failure but systematically reduces sensitivity. False-negative from degradation = missed diagnosis. FFPE DNA/RNA quality significantly declines after 1–2 years. cfRNA degrades within hours at RT; stabilizer mandatory. Each freeze-thaw cycle irreversibly damages sample; aliquot upfront. Temperature excursion beyond allowed = minimum AT_RISK flag. Stability validation must be performed FOR EACH matrix/analyte/condition combination. Absence

URS — User Requirements Specification

input.csv contract

SampleID,PatientID,SampleType,AnalyteTarget,AssayName,CollectionDate,ProcessingDate,AnalysisDate,TimeToProcessing_Hours,MaxTimeToProcessing_Hours,TotalAge_Days,PostProcessingAge_Days,StorageTemperature,RequiredStorageTemperature,StorageCondition_Met,ColdChain_Maintained,TemperatureExcursion_Detected,ExcursionDuration_Hours,MaxAllowedExcursion_Hours,FreezeThawCycles,MaxFreezeThawCycles,StabilizerUsed,Stabilizer_CompatibleWithAssay,ContainerType,Container_Appropriate,MaxStableAge_Processed_Days,MaxStableAge_Unprocessed_Hours,StabilityData_Available,DIN_Score,RIN_Score,DV200_Percent,HemolysisIndex,MaxHemolysisIndex
STAB-2026-001,PAT-LUNG-042,Plasma,cfDNA,NSCLC_CGP,2026-05-15,2026-05-15,2026-06-08,3.0,24,24,24,-80C,-80C,true,true,false,0,2,1,3,Streck,true,Streck_cfDNA_Tube,true,90,72,true,0,0,0,5,50
STAB-2026-002,PAT-CRC-055,FFPE,DNA,CRC_Panel,2024-03-10,2024-03-12,2026-06-08,48,72,818,816,RT,RT,true,false,true,48,24,0,0,Formalin,true,FFPE_Block,true,365,72,true,2.1,0,0,0,50
STAB-2026-003,PAT-RARE-061,CSF,RNA,NeuroPanel,2026-06-01,2026-06-01,2026-06-08,1.0,4,7,7,-80C,-80C,true,true,false,0,1,3,3,None,true,Cryovial,true,30,4,false,0,6.5,72,0,50

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "sampleageandstabilitychecker",
  "utilityFolder": "SampleAgeAndStabilityChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "STAB-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": "Plasma",
      "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": "CollectionDate",
      "value": "2026-05-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "ProcessingDate",
      "value": "2026-05-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "AnalysisDate",
      "value": "2026-06-08",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "TimeToProcessing_Hours",
      "value": "3.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "MaxTimeToProcessing_Hours",
      "value": "24",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "TotalAge_Days",
      "value": "24",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "PostProcessingAge_Days",
      "value": "24",
      "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": "SampleAgeAndStabilityChecker.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.