Xe133VentilationSPECTQC

Xe-133 Ventilation SPECT QC

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

Utility description: Xe-133 Ventilation SPECT QC

Xe-133 Ventilation SPECT QC — Xe-133 Ventilation SPECT Quality Control

ℹ️  Utility evaluates technical parameters of SPECT data acquisition:
    • Total statistics (count number)
    • Detector field of view uniformity
    • Peak count rate

⚠️  CRITICAL: Lack of statistics leads to reconstruction artifacts!
    Crystal non-uniformity creates ring artifacts.

Usage:
  Xe133VentilationSPECTQC.exe                            → demo mode (console output)
  Xe133VentilationSPECTQC.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,ProductName,Admin_MBq,Acq_Time_Min,Matrix,Total_Counts_k,Peak_CPS,Uniformity_Percent,Min_Counts,Max_Unif

Example:
  SPECT-XE133-2026-001,Xe-133 SPECT,740,15,64,850,15000,3.5,500,5

— WHY IS THIS NEEDED?
SPECT quality control is critical for accurate lung ventilation diagnostics:
• Xe-133 has relatively low gamma energy (81 keV), requiring good detector sensitivity
• Iterative reconstruction (OSEM) requires sufficient counts (statistics)
• NaI(Tl) crystal non-uniformity leads to ring artifacts in slices
• Low count rate may indicate collimator or electronics problems
• Utility helps reject non-diagnostic studies before physician reporting

⚠️  CRITICAL:
• Total statistics ≥500 thousand counts (for standard resolution)
• Non-uniformity ≤5% (integral)
• Stable peak count rate
• Correct matrix selection (64x64 or 128x128) depending on zoom

Key features:
• Statistical significance analysis
• Gamma-camera technical condition assessment
• Acquisition parameter control (time, matrix)
• Poor image quality cause detection

Critical parameters:
• Total Counts: ≥500 kcounts
• Uniformity: ≤5%
• Peak Count Rate: > 1000 cps

💡 Usage tips:
1. Perform daily uniformity check with cobalt sheet (Co-57)
2. Increase acquisition time for low administered activity
3. Use correct energy windows for Xe-133 (center 81 keV, width 20%)
4. Monitor system dead time at high activity
5. Calibrate attenuation correction (if CT used) for hybrid systems

⚠️ Note: Ventilation SPECT with gas is more complex than perfusion due to patient motion and need for breathing during acquisition. The utility helps ensure that system technical parameters allow obtaining clear gas distribution picture despite these challenges.

input.csv

BatchNumber,ProductName,Admin_MBq,Acq_Time_Min,Matrix,Total_Counts_k,Peak_CPS,Uniformity_Percent,Min_Counts,Max_Unif
SPECT-XE133-2026-001,Xe-133 SPECT Standard,740,15,64,850,15000,3.5,500,5
SPECT-XE133-2026-002,Xe-133 SPECT (Low Stat),740,5,64,200,14000,3.5,500,5
SPECT-XE133-2026-003,Xe-133 SPECT (Bad Crystal),740,15,64,850,15000,8.0,500,5

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of Xe133VentilationSPECTQC for “Xe-133 Ventilation SPECT 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 Counts: ≥500 kcounts
Uniformity: ≤5%
Peak Count Rate: > 1000 cps

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 SPECT 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	`SPECT-XE133-2026-001`	Batch/lot identifier for traceability.
2	`ProductName`	string	as specified	`Xe-133 SPECT Standard`	Name of the controlled product, gas, procedure or equipment.
3	`Admin_MBq`	decimal	MBq	`740`	Controlled input.csv field: Admin MBq.
4	`Acq_Time_Min`	decimal	min	`15`	Time parameter for processing, relaxation, pumping or examination.
5	`Matrix`	string	as specified	`64`	Controlled input.csv field: Matrix.
6	`Total_Counts_k`	decimal	°C	`850`	Controlled input.csv field: Total Counts k.
7	`Peak_CPS`	decimal	°C	`15000`	Controlled input.csv field: Peak CPS.
8	`Uniformity_Percent`	decimal	%	`3.5`	Signal or field uniformity metric.
9	`Min_Counts`	decimal	°C	`500`	Controlled input.csv field: Min Counts.
10	`Max_Unif`	decimal	as specified	`5`	Controlled input.csv field: Max Unif.

BatchNumber,ProductName,Admin_MBq,Acq_Time_Min,Matrix,Total_Counts_k,Peak_CPS,Uniformity_Percent,Min_Counts,Max_Unif
SPECT-XE133-2026-001,Xe-133 SPECT Standard,740,15,64,850,15000,3.5,500,5
SPECT-XE133-2026-002,Xe-133 SPECT (Low Stat),740,5,64,200,14000,3.5,500,5
SPECT-XE133-2026-003,Xe-133 SPECT (Bad Crystal),740,15,64,850,15000,8.0,500,5

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	`Xe133VentilationSPECTQC.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 SPECT 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-spect-qc",
  "primaryTag": "instrumental",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "SPECT-XE133-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "Xe-133 SPECT 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": "Acq_Time_Min",
      "value": "15",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Matrix",
      "value": "64",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Total_Counts_k",
      "value": "850",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Peak_CPS",
      "value": "15000",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Uniformity_Percent",
      "value": "3.5",
      "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.

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