Xe133VentilationDosimetryAndScavengingQC

Xe-133 Ventilation Dosimetry & Scavenging QC

instrumental Hyperpolarized Xenon RPH Xe-129 medical gases CSV→JSON URS & FS rule-based

Utility description: Xe-133 Ventilation Dosimetry & Scavenging QC

Xe-133 Ventilation Dosimetry & Scavenging QC — Xe-133 Ventilation Dosimetry and Scavenging Control

ℹ️  Utility controls radiation safety during Xe-133 use:
    • Patient effective dose
    • Room air gas concentration
    • Exhaled gas scavenging efficiency

⚠️  CRITICAL: Xe-133 is radioactive (T1/2=5.2 days)!
    Active exhalation filtration system is mandatory.

Usage:
  Xe133VentilationDosimetryAndScavengingQC.exe                            → demo mode (console output)
  Xe133VentilationDosimetryAndScavengingQC.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,ProductName,Admin_MBq,Inhale_Min,Washout_Min,Lung_Dose_mSv,Bladder_Dose_mSv,Total_Dose_mSv,Room_Conc_Bq_m3,Recovery_Percent,Max_Dose,Max_Room_Conc,Min_Recovery

Example:
  XE133-DOSE-2026-001,Xe-133,740,3,5,0.8,0.1,1.2,200,98,2,1000,90

— WHY IS THIS NEEDED?
Xe-133 safety control is critical due to its radioactivity:
• Unlike stable Xe-129, Xe-133 emits gamma quanta and beta particles
• Patient receives radiation dose (mainly to lungs and bladder)
• Exhaled gas is radioactive and must be trapped by special filters (charcoal traps)
• System leaks can lead to room air contamination and staff irradiation
• Utility helps comply with radiation safety standards (NRB) and regulatory requirements

⚠️  CRITICAL:
• Patient effective dose ≤2-3 mSv (typical diagnostic limit)
• Room air concentration ≤1000 Bq/m3 (depends on local regulations)
• Exhalation trapping efficiency ≥90-95%
• Regular replacement of recovery system filters

Key features:
• Individual patient dose assessment
• Room radiation background monitoring
• Scrubber/trap efficiency control
• Support for various administration protocols (bolus, equilibrium)

Critical parameters:
• Total Effective Dose: ≤2.0 mSv
• Room Air Concentration: ≤1000 Bq/m3
• Exhaled Recovery: ≥90%

💡 Usage tips:
1. Use personal dosimeters for staff working with Xe-133
2. Check breathing circuit tightness before each study
3. Replace charcoal filters according to schedule or upon saturation
4. Perform regular background measurements in cabinet after study series
5. Maintain activity log for regulatory reporting

⚠️ Note: Xe-133 requires dual control: medical (patient dose) and environmental (surrounding safety). The utility combines these aspects into a single safety protocol, preventing both patient overexposure and laboratory contamination.

input.csv

BatchNumber,ProductName,Admin_MBq,Inhale_Min,Washout_Min,Lung_Dose_mSv,Bladder_Dose_mSv,Total_Dose_mSv,Room_Conc_Bq_m3,Recovery_Percent,Max_Dose,Max_Room_Conc,Min_Recovery
XE133-DOSE-2026-001,Xe-133 Standard,740,3,5,0.8,0.1,1.2,200,98,2,1000,90
XE133-DOSE-2026-002,Xe-133 (Leak),740,3,5,0.8,0.1,1.2,1500,98,2,1000,90
XE133-DOSE-2026-003,Xe-133 (Bad Trap),740,3,5,0.8,0.1,1.2,200,80,2,1000,90

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of Xe133VentilationDosimetryAndScavengingQC for “Xe-133 Ventilation Dosimetry & Scavenging QC”. Limits from the source description are an initial configuration and shall be reconciled with the approved specification, study protocol, equipment instructions and local SOPs before production use.

Domain constraints and critical parameters

Total Effective Dose: ≤2.0 mSv
Room Air Concentration: ≤1000 Bq/m3
Exhaled Recovery: ≥90%

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept `input.csv` with the exact headers defined by the data contract.	High	The file is processed without manual header renaming.
URS-002	The utility shall perform a deterministic assessment for “Xe-133 Ventilation Dosimetry & Scavenging QC”.	High	PASS / WARNING / FAIL is produced for each row.
URS-003	Required fields, types, ranges, units and data consistency shall be validated before domain rules.	High	Schema errors are separated from nonconformities.
URS-004	Critical limits from the description and approved local configuration shall create a critical finding.	High	A critical rule violation results in FAIL.
URS-005	The result shall be written to machine-readable `output.json`.	High	JSON contains source values, checks, warnings and failures.
URS-006	The conformity decision shall not use machine learning.	Medium	The result is reproducible from explicit rules and inputs.
URS-007	Traceability of batch, source file, rule version and final status shall be retained.	High	QA/QC can reproduce the decision.
URS-008	The utility shall have exactly one primary portal tag: `instrumental`.	Medium	The other api / instrumental / medical_devices tags are absent.
URS-009	Documentation shall support IQ/OQ/PQ or equivalent CSA/CSV verification.	Medium	The contract, test scenarios and change-control rules are supplied with the utility.

input.csv data contract

#	Field	Type	Unit	Sample	Purpose
1	`BatchNumber`	string	as specified	`XE133-DOSE-2026-001`	Batch/lot identifier for traceability.
2	`ProductName`	string	as specified	`Xe-133 Standard`	Name of the controlled product, gas, procedure or equipment.
3	`Admin_MBq`	decimal	MBq	`740`	Controlled input.csv field: Admin MBq.
4	`Inhale_Min`	decimal	min	`3`	Controlled input.csv field: Inhale Min.
5	`Washout_Min`	decimal	min	`5`	Controlled input.csv field: Washout Min.
6	`Lung_Dose_mSv`	decimal	mSv	`0.8`	Calculated dose quantity for a radionuclide procedure.
7	`Bladder_Dose_mSv`	decimal	mSv	`0.1`	Calculated dose quantity for a radionuclide procedure.
8	`Total_Dose_mSv`	decimal	mSv	`1.2`	Calculated dose quantity for a radionuclide procedure.
9	`Room_Conc_Bq_m3`	decimal	Bq	`200`	Room or workplace-monitoring parameter.
10	`Recovery_Percent`	decimal	%	`98`	Xenon capture, recovery or recycling metric.
11	`Max_Dose`	decimal	as specified	`2`	Calculated dose quantity for a radionuclide procedure.
12	`Max_Room_Conc`	decimal	°C	`1000`	Room or workplace-monitoring parameter.
13	`Min_Recovery`	decimal	as specified	`90`	Xenon capture, recovery or recycling metric.

BatchNumber,ProductName,Admin_MBq,Inhale_Min,Washout_Min,Lung_Dose_mSv,Bladder_Dose_mSv,Total_Dose_mSv,Room_Conc_Bq_m3,Recovery_Percent,Max_Dose,Max_Room_Conc,Min_Recovery
XE133-DOSE-2026-001,Xe-133 Standard,740,3,5,0.8,0.1,1.2,200,98,2,1000,90
XE133-DOSE-2026-002,Xe-133 (Leak),740,3,5,0.8,0.1,1.2,1500,98,2,1000,90
XE133-DOSE-2026-003,Xe-133 (Bad Trap),740,3,5,0.8,0.1,1.2,200,80,2,1000,90

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	`Xe133VentilationDosimetryAndScavengingQC.exe` supports demo mode and `input.csv output.json` mode.
FS-002	CSV import	Read UTF-8 CSV and validate header, column count and order.
FS-003	Schema validation	Validate required values, empties, types and basic plausibility.
FS-004	Domain rule engine	Apply explicit rules for “Xe-133 Ventilation Dosimetry & Scavenging QC” and locally approved limits.
FS-005	Status aggregation	FAIL for a critical finding; WARNING for a non-critical deviation; PASS for conformity.
FS-006	JSON export	Write source values, applied rules, statuses, warnings, failures and configuration version.
FS-007	Audit support	Retain a result structure suitable for review, investigation, IQ/OQ and change control.
FS-008	Integration contract	LIMS/ELN/MES or an instrument wrapper creates CSV; the utility returns JSON.

output.json example

{
  "utilityId": "xe133-ventilation-dosimetry-and-scavenging-qc",
  "primaryTag": "instrumental",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "XE133-DOSE-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "Xe-133 Standard",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Admin_MBq",
      "value": "740",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Inhale_Min",
      "value": "3",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Washout_Min",
      "value": "5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Lung_Dose_mSv",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Bladder_Dose_mSv",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Total_Dose_mSv",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "warnings": [],
  "criticalFindings": []
}

OQ/PQ test scenarios

ID	Scenario	Expected result
OQ-001	Valid example row	PASS or an allowed WARNING under local rules.
OQ-002	Required column missing	Schema error; domain checks do not mask it.
OQ-003	Non-numeric value in numeric field	Type-conversion error.
OQ-004	Critical parameter outside its limit	FAIL and a critical finding.
OQ-005	Boundary value	The result follows the configured ≤ / ≥ / < / > operator.
PQ-001	Real site data	Agreed QA/QC review retaining CSV, JSON, version and checksum.

QA/QC and change control

Do not change column names without updating the validator, documentation and test set.
Retain input.csv, output.json, executable version, rule version and checksums.
Before production use, verify local limits and execute IQ/OQ/PQ or equivalent CSA.
Changes affecting patient safety, dosimetry, gas composition, polarization or equipment require documented impact assessment.

Included in packages

Rph Hyperpolarized Xenon Lifecycle QC Suite

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Xe-127, Xe-129 and Xe-133 for ventilation, hyperpolarized imaging, gas QC and safety.

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Lung perfusion, MAA, V/Q, aerosol, xenon ventilation, shunt and pulmonary dosimetry.

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RPH organ/system: renal and urinary

Renography, GFR/ERPF, renal uptake, DMSA/MAG3/DTPA and bladder-related workflows.

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RPH use case: xenon, ventilation and medical gases

Xe-129, Xe-133, Xe-127, hyperpolarization, SEOP, T1, mixing, scavenging, transport, recovery and ventilation imaging.

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RPH workflow: dosimetry and therapy planning

Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.

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RPH workflow: imaging QC and quantitative interpretation

Acquisition, uptake, clearance, perfusion, transit, ejection fraction, segmentation and quantitative imaging.

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