GallbladderEjectionFractionCalculator

Gallbladder Ejection Fraction Calculator

medical-devices radiopharmaceuticals nuclear-medicine tc-99m hida hepatobiliary-imaging liver-function gallbladder
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Gallbladder Ejection Fraction Calculator

Gallbladder Ejection Fraction Calculator

ℹ️  Utility performs:
    • Calculation of gallbladder ejection fraction from background-corrected pre- and post-stimulation counts.
    • input.csv structure and numeric-value validation
    • LabWare-compatible output.json generation
    • Deterministic PASS / FAIL / ERROR status

⚠️  CRITICAL: Any nonconformity shall be reviewed by qualified personnel before the result is used in an operational workflow.

Usage:
  GallbladderEjectionFractionCalculator.exe                            → demonstration mode (console output)
  GallbladderEjectionFractionCalculator.exe input.csv output.json      → evaluate user data

Input format:
BatchNumber,PreStimulusGallbladderCounts,PostStimulusGallbladderCounts,PreBackgroundCounts,PostBackgroundCounts,MinExpectedEjectionFractionPercent,InfusionDurationMin

Example:
  GBEF-001,500000,200000,20000,18000,38,60

— WHY IS THIS NEEDED?
Calculation of gallbladder ejection fraction from background-corrected pre- and post-stimulation counts.
The utility belongs to “RPH Tc-99m Hepatobiliary and HIDA QC Suite” and can be used as a standalone check or as part of a wider nuclear-medicine workflow.

⚠️  CRITICAL:
• CorrectedPreCounts: >0
• GallbladderEjectionFraction: >= protocol minimum
• InfusionDuration: >=30 for this reference profile

Key features:
• One .NET 6 executable and one Program.cs
• Complete input.csv example with passing, boundary and failing records
• LabWare-compatible JSON: Header, Samples, Results, Status, StatusCode, ErrorMessage, Description and DescriptionEN
• CultureInfo.InvariantCulture for numeric values
• Explicit result for every parameter and empty ErrorMessage for PASS

Critical parameters:
• CorrectedPreCounts: >0
• GallbladderEjectionFraction: >= protocol minimum
• InfusionDuration: >=30 for this reference profile

💡 Usage tips:
1. Before operational use, reconcile limits with the approved specification, product information, local SOP and equipment configuration.
2. Retain the source input.csv together with output.json and the executable version.
3. For clinical calculations, use only verified source data and an approved protocol profile.
4. FAIL requires review and is not an automatic medical decision.
5. Limit changes require change control and renewed verification.

⚠️ Note: The utility implements a deterministic CSV-to-LabWare-compatible-JSON workflow and does not replace an approved method, specification, SOP or medical judgement.

The reference limits in this version are a conservative FUZKK project starting profile. They shall be confirmed by the process owner before OQ/PQ and production use.

input.csv

BatchNumber,PreStimulusGallbladderCounts,PostStimulusGallbladderCounts,PreBackgroundCounts,PostBackgroundCounts,MinExpectedEjectionFractionPercent,InfusionDurationMin
GBEF-001,500000,200000,20000,18000,38,60
GBEF-002,450000,280000,20000,18000,38,45
GBEF-003,400000,350000,20000,18000,38,5

URS & FS — user requirements and functional specification

URS — User Requirements Specification

  • The utility shall run without arguments in demonstration mode and with two arguments: input.csv output.json.
  • Mandatory CSV header: BatchNumber,PreStimulusGallbladderCounts,PostStimulusGallbladderCounts,PreBackgroundCounts,PostBackgroundCounts,MinExpectedEjectionFractionPercent,InfusionDurationMin.
  • Numeric values shall be parsed with CultureInfo.InvariantCulture.
  • Each row shall create a separate Samples object in LabWare-compatible JSON.
  • Status shall be PASS, FAIL or ERROR; ErrorMessage shall be empty for PASS.
  • The utility shall apply workflow-specific rules and return a result for every parameter.
  • Repeated execution with the same data and version shall produce an identical result.
  • An invalid header, column count or value type shall produce ERROR, never PASS.

Complete input.csv example

BatchNumber,PreStimulusGallbladderCounts,PostStimulusGallbladderCounts,PreBackgroundCounts,PostBackgroundCounts,MinExpectedEjectionFractionPercent,InfusionDurationMin
GBEF-001,500000,200000,20000,18000,38,60
GBEF-002,450000,280000,20000,18000,38,45
GBEF-003,400000,350000,20000,18000,38,5

FS — Functional Specification

  1. Main() selects demonstration or file mode.
  2. LoadData() validates the exact header and converts each row into Record.
  3. Evaluate() returns a named tuple containing batch number, product, parameters, overall result and RU/EN recommendations.
  4. AddCheck() creates Results items with measured value, unit, limit and IsWithinSpec.
  5. RunWithFiles() builds Header/Samples and serializes the result with Newtonsoft.Json.
  6. A global exception becomes a SampleResult with ERROR status and code -1.

Implemented rules

  • CorrectedPreCounts: >0
  • GallbladderEjectionFraction: >= protocol minimum
  • InfusionDuration: >=30 for this reference profile

Complete input.csv example

BatchNumber,PreStimulusGallbladderCounts,PostStimulusGallbladderCounts,PreBackgroundCounts,PostBackgroundCounts,MinExpectedEjectionFractionPercent,InfusionDurationMin
GBEF-001,500000,200000,20000,18000,38,60
GBEF-002,450000,280000,20000,18000,38,45
GBEF-003,400000,350000,20000,18000,38,5

Minimum OQ scenarios

  • PASS for the first row.
  • Boundary-record processing for the second row.
  • FAIL for the third row.
  • ERROR for an altered header.
  • ERROR for a non-numeric value.
  • Identical JSON result on repeated execution.

Included in packages

PetRad QC Suite

A specialised utility package for radiopharmaceutical quality control: PET, SPECT, therapeutic radionuclides, generators and decay calculations.

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PetRad3: expanded PET/SPECT and radiopharmaceutical QC package

A curated suite for PET/SPECT radiopharmaceuticals, generator and cyclotron radionuclides, labelled compounds, radiochemical purity, breakthrough, sterility and endotoxin control.

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Radiology QC Suite

QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.

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Tc-99m radiopharmaceuticals, kit preparation, generator control, SPECT workflows and calculation utilities.

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RPH organ/system: cardiovascular

Myocardial perfusion, cardiac PET/SPECT, ventricular function, blood-pool and perfusion tracers.

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RPH organ/system: hepatobiliary and GI

HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.

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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 Tc-99m Hepatobiliary and HIDA QC Suite

Quality control of HIDA, mebrofenin and disofenin, hepatic extraction and gallbladder ejection calculations, and hepatobiliary transit review.

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RPH use case: HIDA, hepatobiliary and GI nuclear medicine

Hepatobiliary tracers, pertechnetate for Meckel/gastric mucosa, gastric emptying, GI transit, RBC bleeding and liver/spleen sulfur colloid.

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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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RPH: combined radiopharmaceutical QC package

RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.

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