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Minnesota Administrative Rules

4732.1100 INSTALLATION CALIBRATION TESTS AND EQUIPMENT PERFORMANCE TESTS FOR A QUALITY ASSURANCE PROGRAM.

Subpart 1.

Tests required.

A.

Installation calibration tests must be conducted prior to any patient use. Any adjustments must be made to bring the equipment up to a nationally recognized standard such as Code of Federal Regulations, title 21, section 1020, or the manufacturer's specifications, and to ensure compliance with this chapter prior to first use.

B.

Equipment performance tests must be conducted over all clinical ranges, when applicable. For equipment performance tests, any adjustments must be made to bring equipment to a nationally recognized standard or manufacturer's specifications; and to ensure compliance with this chapter prior to using the equipment again.

Subp. 2.

Frequency of tests.

The tests in this part are to be made at the time of installation and at the specified intervals thereafter.

Subp. 3.

Image receptors.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Screen-film contact At intervals not to exceed 24 months No significant areas of poor contact as measured by no less than:
(1) 8 wires/inch mesh; or
(2) 7 holes/inch for regular film;
(3) 40 wires/inch mesh or greater for mammography film
B. Screen-film-
cassette speed match
At intervals not to exceed 24 months Densities within ± 0.10 O.D. for all cassettes of the same speed used for imaging
C. CR imaging plates At intervals not to exceed three months or upon observation of image artifacts Follow manufacturer's recommendations

Subp. 4.

Processing.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Darkroom fog At intervals not to exceed six months < 0.08 O.D. increase in density (measured at approximately 1.00 O.D.) after 2 minutes using film exposed on-site at the time of test. For mammography the O.D. increase must be < 0.05
B. Sensitometry and densitometry Before processing first film of the day Density difference ± 0.15 O.D. and base + fog + .05 O.D. using film exposed on-site at time of test. Veterinary facilities are not required to perform this test
C. Temperature check At the time of sensitometry Follow manufacturer's recommendations

Subp. 5.

All diagnostic radiographic tubes; required when applicable.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. SID indicator accuracy At intervals not to exceed 24 months ± 2% of indicated value
B. X-ray and light field alignment At intervals not to exceed 24 months ± 2% of SID any one direction, ± 3% of SID, both directions (total)
C. X-ray and image receptor alignment At intervals not to exceed 24 months ± 2% of SID
D. Collimator dial accuracy At intervals not to exceed 24 months ± 2% of SID
E. Reproducibility At intervals not to exceed 24 months Coefficient of variation < 5%
F. mR/mAs At intervals not to exceed 24 months ± 10% of baseline
G. Linearity At intervals not to exceed 24 months ± 10% over clinical range
H. Linearity - for mAs only units manufactured after May 3, 1994 At intervals not to exceed 24 months Average ratios of exposure to the indicated mAs obtained in any two consecutive mAs settings must not differ by more than 0.10 times their sum, or at two settings differing by no more than a factor of two where the mAs selector provides continuous selection
I. Timer accuracy At intervals not to exceed 24 months Single Phase: ± 10% of setting. Three phase, high frequency, and constant potential: use ± 5% of selected time when measured > 100 milliseconds. At times shorter than 100 milliseconds, use manufacturers' specifications
J. Half-value layer At intervals not to exceed 24 months Must meet requirements in part 4732.0810
K. kVp accuracy At intervals not to exceed 24 months ± 5% of indicated kVp
L. Phototimer reproducibility, if present At intervals not to exceed 24 months ± 5% of average exposure
M. AEC (phototimer) At intervals not to exceed 24 months ± 10% of manufacturer's state increments
N. Illuminance of collimator At intervals not to exceed 24 months > 15 footcandles
O. Film density vs. thickness change on AEC At intervals not to exceed 24 months ± 0.30 O.D. of the averaged exposures over the range specified by the manufacturer
P. Film density vs. kVp change on AEC At intervals not to exceed 24 months ± 0.30 O.D. of the averaged exposures when measured at > 1.2 O.D. and over the range as specified by the manufacturer
Q. Spot film reproducibility (fluoroscopy units with manual mode) At intervals not to exceed 24 months ± 5% of average exposure
R. Phototimer back-up timer cut off At time of installation Terminates exposure at < 600 mAs
S. AEC density at normal or "0" At intervals not to exceed 24 months > 1.0 O.D.

Subp. 6.

For facilities with fluoroscopes and C-arm fluoroscopes, except radiation therapy simulators, manufactured before May 19, 1995.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Maximum output at tabletop or equivalent minimum SSD At intervals not to exceed 12 months and every tube change < 5 R (1.3 mC/kg) per minute for manual; < 10 R (2.6 mC/kg) per minute for automatic exposure rate control systems
B. High level control maximum output at tabletop or equivalent minimum SSD At intervals not to exceed 12 months and every tube change < 20 R (5.0 mC/kg-1) per minute
C. Fluoroscopic image size At intervals not to exceed 12 months and every tube change Error between fluorographic beam size and observed image size must be no more than ± 3% of SID for all modes and at any tower height
D. Actual spot-film size vs. indicated At intervals not to exceed 12 months Error between actual fluorographic beam size at image receptor and indicated image size must be no more than ± 3% of SID for all modes and at any tower height
E. Spot-film reproducibility At intervals not to exceed 12 months ± 5% of average exposure
F. Phototimer reproducibility, if present At intervals not to exceed 12 months ± 5% of average exposure
G. Fluoroscopic high contrast resolution and distortion At intervals not to exceed 12 months Six inch (15 centimeter) intensifier: center 30 and edge 24 (wires per inch) copper mesh; nine inch (23 centimeter) intensifier
H. Half-value layer At intervals not to exceed 12 months and after every tube change ± 5% for equipment manufactured before 1973. For equipment manufactured after 1973, follow manufacturer's specified limits

Subp. 7.

For facilities with fluoroscopes and C-arm fluoroscopes, except radiation therapy simulators, manufactured on or after May 19, 1995.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Maximum output at tabletop or equivalent minimum SSD At intervals not to exceed 12 months and at every tube change > 5 R/min must have automatic exposure rate control; > 10 R/min must have high level control; if not high level control maximum is < 10 R/min
B. High level control maximum output at tabletop or equivalent minimum SSD At intervals not to exceed 12 months and at every tube change < 20 R/min
C. All other tests as indicated in subpart 5 At intervals not to exceed 24 months See criteria in subpart 5

Subp. 8.

For facilities with tomography systems other than computed tomography.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Section level At intervals not to exceed 12 months ± 5 millimeters
B. Level incrementation At intervals not to exceed 12 months ± 2 millimeters
C. Section thickness (slice width) At intervals not to exceed 12 months Follow manufacturer's specifications
D. All other tests in part 4732.1000 if applicable At intervals not to exceed 24 months See criteria in subpart 4
E. Spatial plane resolution At intervals not to exceed 12 months 40 mesh screen or better

Subp. 9.

For facilities with computed tomography scanners.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Accuracy of scout localization view At intervals not to exceed 12 months ± 1 millimeters
B. Accuracy of distance measurements At intervals not to exceed 12 months ± 1 millimeters
C. CT dose index At intervals not to exceed 12 months ± 20% from manufacturer's recommendations
D. CT number dependence on slice thickness At intervals not to exceed 12 months Mean ± 3 CT numbers averaged over 100 pixels
E. CT number calibration and noise Daily Water: 0 ± 5 CT numbers; Noise: ± 3 standard deviations of the mean of the baseline noise variance measurements
F. CT number uniformity and artifacts Monthly for mobile units. At intervals not to exceed 12 months for fixed base units. Variation ± 5 CT numbers between the mean values of measurements made at center and edge of phantom that is at least 20 cm. In diameter among a mean of 100 pixels. Artifacts: no noticeable artifacts
G. Hard copy output and visual display Daily Luminance and contrast not significantly different
H. Table indexing At intervals not to exceed six months ± 0.5 millimeter for each increment
I. Table backlash At intervals not to exceed six months ± one millimeter

Subp. 10.

For facilities with cinefluorographic and special procedure systems.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Cinefluorographic exposure rates At intervals not to exceed 12 months Approximately 10 to 20 µR (2.6 to 5.0 nC/kg) per frame at intensifier for nine inch (23 cm) mode; approximately 20 to 30 µR (5 to 8 nC/kg) per frame at intensifier for six inch (15 cm) mode
B. All tests in subparts 4, 5, and 6, if applicable At intervals not to exceed 24 months See criteria in subparts 4, 5, and 6
C. Film changer screen-film contact At intervals not to exceed 24 months No significant areas of poor contact as measured by no less than: (1) 8 wire per inch mesh; or (2) 7 holes per inch
D. High contrast resolution for cinefluorographic and digital systems At intervals not to exceed 12 months No significant difference between static and dynamic conditions
E. Optical density of films over duration of filming run At intervals not to exceed 12 months < ± 0.2 O.D. difference

Subp. 11.

For facilities with dental intraoral systems.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Film processing Before the first film of the day Between 0.75 and 1.05 O.D. on the test tool or follow test tool manufacturer's recommendations
B. Fog test At intervals not to exceed six months Unable to visualize coin edges
C. Filtration (HVL) At intervals not to exceed 24 months Meet requirements in part 4732.0800
D. Radiation exposure at the end of cone At intervals not to exceed 24 months Meet requirements in part 4732.0825
E. Timer reproducibility At intervals not to exceed 24 months ± 10% of indicated timer setting
F. kVp accuracy At intervals not to exceed 24 months ± 5% of indicated kVp for equipment manufactured before 1973. For equipment manufactured after 1973, follow manufacturer's specified limits
G. Exposure output reproducibility At intervals not to exceed 24 months Coefficient of variation < 5%
H. Dental mA linearity At intervals not to exceed 24 months ± 10% over the clinical range

Subp. 12.

For facilities with dental extraoral systems including panoramic systems.

TEST TYPE MINIMUM TEST INTERVAL MINIMUM PERFORMANCE CRITERIA
A. Film processing Before the first film of the day Use processing as specified in subpart 3. A step wedge may be used. ± one step from standard allowed
B. Fog test At intervals not to exceed six months Use criteria in subpart 3, item A, for automatic processing; subpart 4, item A, for manual processing
C. Same test types and minimum performance criteria as in diagnostic radiographic tubes in subpart 4 At intervals not to exceed 24 months See criteria in subpart 4

Statutory Authority:

MS s 144.12

History:

32 SR 777

Published Electronically:

December 10, 2007

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