S.C. Code Regs. § ch. 61, 61-64, pt. IV, app 61-64.IV.F

Current through Register Vol. 48, No. 10, October 25, 2024
Appendix 61-64.IV.F - Minimum Criteria for Performance Tests

The following items must be tested. Each item tested must include an indication of Pass/Fail, Compliant/ Non-compliant, as required by RHB 2.8.3.6. Each record of equipment performance testing shall be legible and include company name, service person name, and the date of the test, and all applicable requirements of RHB 2.8.3.6.5.

MEDICAL RADIOGRAPHIC (Including veterinary facilities)

1. Half-value layer (HVL) (4.3.5)

2. X-ray field/light field alignment (4.7.1.3, 4.8.4)

3. Exposure reproducibility (4.7.5)

4. mA/mAs linearity (4.7.7)

5. kVp accuracy (4.7.6)

6. Timer reproducibility and accuracy (4.7.4.2.6, 4.7.6)

7. X-ray beam/image receptor centering (4.7.1.7)

8. Collimator light illuminance (4.7.8)

9. Actual vs. indicated collimator field sizes (4.7.1.5, 4.8.6)

10. Positive beam limitation function, if operable (4.7.12)

11. Visual and audible indication of exposure (4.7.4.2.3)

12. Minimum field size (4.7.14)

13. Patient exposure at skin entrance, for most common exams clinically performed at the facility to include the source-to-image receptor distance (SID) used. If at least one of these exams is not represented in Appendix D, an exam type listed in Appendix D clinically performed at the facility shall also be evaluated. (Techniques clinically used by the facility must be used to evaluate patient exposure at skin entrance) (except veterinary facilities) (4.2.13.2)

14. Proper function of automatic exposure control devices, including AEC reproducibility, kV compensation, and minimum response time (4.7.4.2.5)

15. Grid uniformity and alignment (4.2.16.3)

16. Actual vs. Indicated SID, for all clinically used SIDs (4.7.11)

17. Beam size(s) for fixed collimation, if applicable (4.7.3)

18. X-ray control placement (Appendix C, 3a)

These items must be checked upon initial installation and after any maintenance or repair that could affect its status:

1. Minimum source-to-skin distance on mobile radiographic units (4.8.11)

2. Proper indication of multiple tubes on units so equipped (4.3.7)

FLUOROSCOPIC

1. X-ray beam/Viewed image size comparison (4.9.2.2)

2. Exposure rate output measurement, using average techniques, using maximum techniques, and in high level exposure mode, if so equipped, in each mode routinely used (4.9.4)

3. Image intensifier interlock with unit in park position (4.9.2.1.2)

4. Cumulative timer function (4.9.7.1)

5. Control of scattered radiation (4.9.8)

6. High contrast resolution and low contrast performance (4.9.12)

7. Minimum source-to-skin distance, upon initial installation (4.9.1)

8. Spot film beam size (4.9.2.3.2)

9. Spot film beam centering (4.9.2.3.4)

10. Spot film exposure reproducibility (4.9.9.3)

11. Spot film mA/mAs linearity (4.7.7)

12. Spot film timer reproducibility and accuracy (4.9.9.2, 4.7.6)

13. Proper function of spot film automatic exposure control devices, including AEC reproducibility, kV compensation, and minimum response time (4.7.4.2.5)

14. Half-value layer (HVL) (4.3.5)

15. Cinefluorographic exposure rates (4.9.4)

16. Integrity of bucky slot cover shielding and lead drapes (4.9.8)

17. Continuous indication of kV and mA during fluoroscopy (4.9.6)

18. X-ray control placement (Appendix C, 3a)

Primary Barrier Transmission (4.9.5) must be checked upon initial installation and after any maintenance or repair that could affect its status.

RADIATION THERAPY SIMULATION SYSTEMS

1. Half-value layer (HVL) (4.3.5)

2. X-ray field/light field alignment (4.7.1.3)

3. Exposure reproducibility (4.7.5)

4. mA/mAs linearity (4.7.7)

5. kVp accuracy (4.7.6)

6. Timer reproducibility and accuracy (4.7.4.2.6, 4.7.6)

7. X-ray beam/image receptor centering (4.7.1.7)

8. Actual vs. indicated collimator field sizes (4.7.1.5)

9. Positive beam limitation function, if operable (4.7.12)

10. Visual and audible indication of exposure (4.7.4.2.3)

11. Proper function of automatic exposure control devices, including AEC reproducibility, kV compensation, and minimum response time (4.7.4.2.5)

12. Grid uniformity and alignment (4.2.16.3)

13. Actual vs. Indicated Source-to-Image Receptor Distance (SID), for all clinically used SIDs (4.7.11)

14. Exposure rate output measurement, using average techniques, using maximum techniques, and in high level exposure mode, if so equipped, in each mode routinely used (4.9.4)

15. Cumulative timer function (4.9.7.1)

16. Measurement of scattered radiation (4.9.8)

17. High contrast resolution and low contrast performance

18. Minimum source-to-skin distance, upon initial installation (4.9.1)

19. X-ray control placement (Appendix C, 3a)

COMPUTED TOMOGRAPHY (CT) (Including CT treatment planning systems used in radiation therapy, PET CT and SPECT CT if used for diagnostic CT imaging, and Cone Beam CT and Dental CT, where applicable)

1. Geometric factors and alignment including alignment light accuracy and table increment accuracy

2. Image localization from scanned projection radiograph (localization image)

3. Radiation beam width

4. Image quality including high-contrast (spatial) resolution, low-contrast resolution, image uniformity, noise, and artifact evaluation

5. CT number accuracy

6. Image quality for acquisition workstation display devices

7. A review of the results of the routine QC required under RHB 4.11.3.2 (CT) or 4.11.5.1 (CBCT)

8. Dosimetry

9. Visible and audible signals

10. X-ray control placement (Appendix C, 3a)

11. Radiation output (patient dose) for the following clinical protocols if performed: pediatric head; pediatric abdomen; adult head; adult abdomen (CT systems solely used for treatment planning in radiation therapy are exempt from this item)

DENTAL

1. Half-value layer (HVL) (4.3.5)

2. Exposure reproducibility (4.5.5)

3. mA/mAs linearity (4.5.6)

4. kVp accuracy (4.5.7)

5. Timer reproducibility and accuracy (4.5.3.3, 4.5.7)

6. Visual and audible indication of exposure (4.5.4.2.4)

7. Patient exposure at skin entrance, bitewing, and/or periapicals (Techniques clinically used by the facility must be used to evaluate patient exposure at skin entrance) (except veterinary facilities) (4.2.13.2)

8. Mechanical support of tubehead (4.5.10)

9. Integrity of pass through interlocks (4.5.11.3)

10. X-ray control placement (4.5.4.2)

These items must be checked upon initial installation and after any maintenance or repair that could affect its status:

1. Minimum source-to-skin distance (4.5.1)

2. X-ray beam size (4.5.2)

3. Proper indication of multiple tubes on units so equipped (4.5.9)

NOTE: Cephalometric units are considered medical units by the Department, and are subject to the requirements for medical radiographic units.

S.C. Code Regs. ch. 61, 61-64, pt. IV, app 61-64.IV.F

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.

Cephalometric units are considered medical units by the Department, and are subject to the requirements for medical radiographic units.