MolecularDxSampleAcceptanceChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of MolecularDxSampleAcceptanceChecker for Molecular Dx Sample Acceptance Checker.

Domain limits and critical parameters

• Comprehensive pre-analytical sample verification at intake per CAP/CLIA, ISO 15189, AMP and ESMO: identification & documentation (label match, requisition, consent, chain of custody), specimen adequacy (volume, tumor content ≥20%, cell count), pre-analytical timing (cold ischemia, FFPE fixation 6–72h, fixative type), quality indicators (hemolysis ≤50, lipemia ≤100, DIN/RIN integrity, DNA yield), and transport conditions (packaging, temperature, biohazard label). Adaptive logic by sample type (FF
• ⚠️ Critical: Up to 70% of molecular dx errors are pre-analytical. Label mismatch = ABSOLUTE REJECT. Over-fixation (>72h) irreversibly degrades nucleic acids. Hemolysis >50 renders plasma unsuitable. Sample may be technically ACCEPTED but clinically CONDITIONAL.

URS — User Requirements Specification

input.csv contract

SampleID,PatientID,OrderedTest,SampleType,LabelMatch,RequisitionComplete,InformedConsent_Present,ChainOfCustody_Complete,SampleVolume_mL,MinVolume_mL,TumorContent_Percent,MinTumorContent_Percent,CellCount_Million,MinCellCount_Million,ColdIschemia_Hours,MaxColdIschemia_Hours,FixationTime_Hours,MinFixation_Hours,MaxFixation_Hours,Fixative,HemolysisIndex,MaxHemolysisIndex,LipemiaIndex,MaxLipemiaIndex,DNA_Yield_ng,MinDNA_Yield_ng,DIN_RIN_Score,MinDIN_RIN_Score,PackagingIntact,TemperatureCondition_Met,BiohazardLabel_Present
MDX-2026-001,PAT-LUNG-042,NSCLC_CGP_Panel,FFPE,true,true,true,true,0,0,45,20,0,0,0.5,24,24,6,72,NBF,0,50,0,100,250,50,3.2,2.0,true,true,true
MDX-2026-002,PAT-BRCA-018,BRCA1_2_Germline,FFPE,false,true,true,true,0,0,10,20,0,0,2,24,120,6,72,NBF,0,50,0,100,35,50,1.8,2.0,true,true,true
MDX-2026-003,PAT-HEM-007,Myeloid_NGS_Panel,Whole_Blood,true,true,true,true,2.5,3.0,0,0,15,5,18,24,0,0,0,,65,50,12,100,180,50,7.5,2.0,true,true,true

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "moleculardxsampleacceptancechecker",
  "utilityFolder": "MolecularDxSampleAcceptanceChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "MDX-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": "OrderedTest",
      "value": "NSCLC_CGP_Panel",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "SampleType",
      "value": "FFPE",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "LabelMatch",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "RequisitionComplete",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "InformedConsent_Present",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "ChainOfCustody_Complete",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "SampleVolume_mL",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "MinVolume_mL",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "TumorContent_Percent",
      "value": "45",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "MinTumorContent_Percent",
      "value": "20",
      "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": "MolecularDxSampleAcceptanceChecker.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.