TreatmentChartAuditor
Treatment Chart Auditor
Treatment Chart Auditor — Treatment Chart Audit (AAPM TG-275) ℹ️ The utility performs comprehensive check of patient's electronic or paper treatment chart before course start or during treatment. ℹ️ Controlled parameters: presence of all mandatory signatures, prescribed vs plan dose match, date logic, fractionation progress. ℹ️ Processing: only the FIRST record in input.csv file. ⚠️ Critical for safety! Errors in treatment chart (wrong dose, missing physicist signature) cause serious incidents. Usage: TreatmentChartAuditor.exe → demo mode TreatmentChartAuditor.exe input.csv output.json → audit data (first record only) Input format: PatientID,PlanName,PrescribedDoseGy,PlanDoseGy,TotalFractions,DeliveredFractions,StartDate,EndDate,PhysicianSigned,PhysicistSigned,TechnologistChecked,ConsentFormPresent Example (boolean values True/False): PT-2026-LUNG-05,Lung_SBRT_5fx,50.0,50.0,5,2,2026-04-01T09:00:00Z,2026-04-10T09:00:00Z,True,False,True,True — WHY IS THIS NEEDED? Before each course and weekly during treatment, chart round is performed. • Missing physicist signature means plan is not verified. • Mismatch between Prescription and Plan dose may indicate entry error. • Dates must be logical (Start < End). • Delivered fractions must not exceed planned. • Automation eliminates "inattention blindness" risk when manually checking hundreds of charts. ⚠️ CRITICAL: • Signatures: Physician, Physicist, Technologist — mandatory. Patient Consent — mandatory. • Dose: Difference > 0.1 Gy unacceptable. • Fractions: Delivered > Total — critical error (overdose). • FAIL status blocks treatment until resolved. Critical parameters: • Signatures: All must be True • Dose Match: Abs(Prescribed - Plan) <= 0.1 Gy • Fractions: Delivered <= Total • Dates: Start < End ⚠️ Note: Utility generates list of missing signatures and specifies rejection reason. Result includes status (PASS/WARNING/FAIL) and bilingual recommendation (RU/EN).
input.csv
PatientID,PlanName,PrescribedDoseGy,PlanDoseGy,TotalFractions,DeliveredFractions,StartDate,EndDate,PhysicianSigned,PhysicistSigned,TechnologistChecked,ConsentFormPresent PT-2026-LUNG-05,Lung_SBRT_5fx,50.0,50.0,5,2,2026-04-01T09:00:00Z,2026-04-10T09:00:00Z,True,False,True,True
URS & FS — user requirements and functional specification
This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.
1. Scope
The Treatment Chart Auditor utility is used for Treatment Chart Auditor. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.
The utility does not use machine learning; decisions are produced by deterministic rules.
Categories: Radiation physics
Tags: activity, brachytherapy, dosimetry, source calibration, TG-43
2. Execution modes
TreatmentChartAuditor.exe → demo mode TreatmentChartAuditor.exe input.csv output.json → audit data (first record only)
3. Key controlled areas
- pH and physicochemical parameters
- activity, decay and radiochemical purity
4. Domain limits and critical parameters
- ⚠️ Critical for safety! Errors in treatment chart (wrong dose, missing physicist signature) cause serious incidents.
- Dates must be logical (Start < End).
- ⚠️ CRITICAL:
- Signatures: Physician, Physicist, Technologist — mandatory. Patient Consent — mandatory.
- Dose: Difference > 0.1 Gy unacceptable.
- Fractions: Delivered > Total — critical error (overdose).
- FAIL status blocks treatment until resolved.
- Critical parameters:
- Signatures: All must be True
- Dose Match: Abs(Prescribed - Plan) <= 0.1 Gy
- Fractions: Delivered <= Total
- Dates: Start < End
- ⚠️ Note: Utility generates list of missing signatures and specifies rejection reason. Result includes status (PASS/WARNING/FAIL) and bilingual recommendation (RU/EN).
5. URS — user requirements
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The system shall accept an input.csv file for Treatment Chart Auditor with the exact columns listed in the “Input data contract” section. | High | A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error. |
| URS-002 | The system shall support execution without arguments in demo mode and execution with input.csv output.json for user data. | Medium | Both execution scenarios produce a predictable result or clear diagnostic error. |
| URS-003 | The system shall perform rule-based controls for: pH and physicochemical parameters, activity, decay and radiochemical purity. | High | Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML. |
| URS-004 | The system shall preserve traceability between batch/lot, source values, applied rules and final verdict. | High | Output includes batch identifier, source values, parameter statuses and critical findings. |
| URS-005 | The system shall generate machine-readable output.json for LIMS/ELN/MES, batch record and QA/QC review. | High | JSON contains overall status, check array, warnings, failures and source-file reference. |
| URS-006 | The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks. | High | The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval. |
| URS-007 | The system shall clearly separate technical data errors from specification nonconformities. | Medium | Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately. |
6. input.csv data contract
The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.
| # | Column | Type | Unit | Description | Sample | Control rule |
|---|---|---|---|---|---|---|
| 1 | PatientID | text | as specified | Patient ID | PT-2026-LUNG-05 | mandatory value; format and acceptability are checked by the utility |
| 2 | PlanName | text | as specified | Plan Name | Lung_SBRT_5fx | mandatory value; format and acceptability are checked by the utility |
| 3 | PrescribedDoseGy | decimal | as specified | Prescribed Dose Gy | 50.0 | mandatory numeric value; rule comparison is performed by the utility |
| 4 | PlanDoseGy | decimal | as specified | Plan Dose Gy | 50.0 | mandatory numeric value; rule comparison is performed by the utility |
| 5 | TotalFractions | decimal | as specified | Total Fractions | 5 | mandatory numeric value; rule comparison is performed by the utility |
| 6 | DeliveredFractions | decimal | as specified | Delivered Fractions | 2 | mandatory numeric value; rule comparison is performed by the utility |
| 7 | StartDate | date/time | as specified | Start Date | 2026-04-01T09:00:00Z | mandatory value; format and acceptability are checked by the utility |
| 8 | EndDate | date/time | as specified | End Date | 2026-04-10T09:00:00Z | mandatory value; format and acceptability are checked by the utility |
| 9 | PhysicianSigned | decimal | as specified | Physician Signed | True | mandatory value; format and acceptability are checked by the utility |
| 10 | PhysicistSigned | decimal | as specified | Physicist Signed | False | mandatory value; format and acceptability are checked by the utility |
| 11 | TechnologistChecked | text | as specified | Technologist Checked | True | mandatory value; format and acceptability are checked by the utility |
| 12 | ConsentFormPresent | text | as specified | Consent Form Present | True | mandatory value; format and acceptability are checked by the utility |
CSV example
PatientID,PlanName,PrescribedDoseGy,PlanDoseGy,TotalFractions,DeliveredFractions,StartDate,EndDate,PhysicianSigned,PhysicistSigned,TechnologistChecked,ConsentFormPresent PT-2026-LUNG-05,Lung_SBRT_5fx,50.0,50.0,5,2,2026-04-01T09:00:00Z,2026-04-10T09:00:00Z,True,False,True,True
7. FS — functional specification
| ID | Function | Implementation description |
|---|---|---|
| FS-001 | CLI entry point | The executable TreatmentChartAuditor.exe supports demo mode and input.csv output.json processing mode. |
| FS-002 | CSV parser | The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator. |
| FS-003 | Field conversion | Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag. |
| FS-004 | Domain rule engine | For Treatment Chart Auditor, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check. |
| FS-005 | Criticality handling | Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS. |
| FS-006 | JSON writer | output.json stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages. |
| FS-007 | Integration contract | The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service. |
| FS-008 | Error handling | Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS. |
8. output.json contract
The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.
{
"utility": "TreatmentChartAuditor",
"api": "Treatment Chart Auditor",
"batchNumber": "",
"overallStatus": "PASS|WARNING|FAIL",
"checkedAtUtc": "2026-05-18T00:00:00Z",
"checks": [
{
"parameter": "PatientID",
"value": "PT-2026-LUNG-05",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "PlanName",
"value": "Lung_SBRT_5fx",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "PrescribedDoseGy",
"value": "50.0",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "PlanDoseGy",
"value": "50.0",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "TotalFractions",
"value": "5",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "DeliveredFractions",
"value": "2",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "StartDate",
"value": "2026-04-01T09:00:00Z",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "EndDate",
"value": "2026-04-10T09:00:00Z",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
}
],
"criticalFindings": [],
"sourceFile": "input.csv"
}9. OQ/PQ test scenarios
| ID | Scenario | Expected result |
|---|---|---|
| TC-001 | Valid CSV with expected header and sample row | All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail. |
| TC-002 | A mandatory input.csv column is missing | Import is rejected or the row receives FAIL with schema reference. |
| TC-003 | A numeric field contains text or a blank value | Type conversion error is recorded; the result is not hidden as PASS. |
| TC-004 | A parameter is outside specification or critical limit | Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule. |
10. QA/QC, CSV and change control
- Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
- Column names must not be changed without updating the validator and test scenarios.
- The source CSV, output.json and utility version should be stored together as an evidence package.
- Any change in control rules must go through change control and repeated OQ scenario verification.
Included in packages
Radiation Physics QC Suite
Utilities for activity, dosimetry, brachytherapy sources, small-field corrections and TG-43 parameters.
OpenRPH organ/system: brain and CNS
Brain perfusion, dopamine transporter, amyloid/tau, receptor imaging and neurological SPECT/PET.
OpenRPH organ/system: hepatobiliary and GI
HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.
OpenRPH organ/system: pulmonary and ventilation
Lung perfusion, MAA, V/Q, aerosol, xenon ventilation, shunt and pulmonary dosimetry.
OpenRPH use case: PET scanner state, gamma camera and radiation physics
The linked medical-device/radiation-physics layer: PET detector QC, normalization, AC map, cross-calibration, TOF, gamma-camera uniformity, source strength and staff dose.
OpenRPH workflow: dosimetry and therapy planning
Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.
OpenRPH workflow: instruments, devices and radiation safety
PET/gamma-camera state, calibration, detector QC, energy window, TOF, shielding and radiation safety.
Open