Radiation Protection in Mammography: Recommended Safety Procedures for the Use of Mammographic X-Ray Equipment - Safety Code 33
8. Quality Control procedures
in mammography
There are two types of Quality Control procedures in
mammography. Initially, there are procedures performed at the
implementation of the Quality Assurance program. Subsequently,
there are procedures carried out during the operation of the program.
Consultation with a medical physicist or an expert in Quality
Assurance for mammography should be done from time to time to
reassess the operation of the program.
8.1 Quality Control equipment
It is essential that the necessary Quality Control test equipment
be provided to the Quality Control technologist or medical physicist.
It is suggested that the required test equipment be acquired when
mammographic X-ray equipment is purchased. It is also important
that the Quality Control technologist or medical physicist be trained
in the proper use of the test equipment.
If the facility elects to perform all Quality Control tests including
testing carried out during implementation of the program to establish
baseline values, daily Quality Control monitoring, and tests to verify
the on-going performance of the mammographic X-ray system, the
test equipment listed in Table 3 is required. If a facility elects instead
to only perform daily Quality Control testing and some of the tests to
verify the on-going performance of the mammographic X-ray system,
the equipment listed in Table 4 is recommended. It is, therefore,
assumed that the organization or individual which provides the
testing service will supply its own test equipment.
Table 3:Quality Control Equipment (complete set)
| Equipment |
Accuracy |
Reproducibility |
| Sensitometer |
± .02 log
exposure units |
± .02 log
exposure units |
| Densitometer |
± .02 O.D.
at 1.0 O.D. |
±.01 O.D.
at 1.0 O.D. |
| Dosimeter |
± 5% |
± 1% |
| Thermometer |
± 0.3°C |
± 0.1°C |
| Non-invasive X-ray |
|
|
| tube voltage meter |
± 1.5 kVp |
± 0.5 kVp |
| Irradiation time meter |
± 5% |
± 1% |
| Light meter |
± 10% |
± 5% |
| Phantom, PMMA, 4.2 cm or |
± 0.02 cm |
- |
| Breast tissue equivalent |
|
|
| material, 4.5 cm |
|
|
| Phantom, PMMA, with image |
- |
- |
| quality evaluation objects |
|
|
| Aluminum filters |
1% thickness |
- |
| (> 99.99% purity) |
|
|
| Mammographic step wedge |
- |
- |
| Compression force test device |
± 10% |
± 5% |
| Focal spot test device |
- |
- |
| Stopwatch |
- |
- |
| Film/screen |
- |
- |
| contact test tool |
|
|
| Fixer retention test kit |
- |
- |
| Magnifying glass |
- |
- |
| Ultraviolet light |
- |
- |
| Ruler |
- |
- |
| Rubber foam for |
|
|
| compression plate alignment |
- |
- |
| Lead sheets |
- |
- |
| Metallic coins |
- |
- |
Table 4: Quality Control Equipment (basic set)
| Equipment |
Accuracy |
Reproducibility |
| Sensitometer |
± .02 log
exposure units |
± .02 log
exposure units |
| Densitometer |
± .02 O.D.at 1.0 O.D. |
± .01 O.D.at 1.0 O.D. |
| Thermometer |
± 0.3°C |
± 0.1°C |
| Phantom, PMMA, 4.2 cm or |
± 0.02 cm |
- |
| Breast tissue equivalent |
|
|
| material, 4.5 cm |
|
|
| Phantom, PMMA, with image |
- |
- |
| quality evaluation objects |
|
|
| Compression force test device |
± 10% |
± 5% |
| Stopwatch |
- |
- |
| Film/screen contact test tool |
- |
- |
| Fixer retention test kit |
- |
- |
| Magnifying glass |
- |
- |
| Ultraviolet light |
- |
- |
| Ruler |
- |
- |
8.2 Mammographic X-ray
system evaluation
During the implementation phase of the Quality Assurance program,
the establishment of baseline information and X-ray equipment
performance is necessary. After initial evaluation, and at regular
intervals during clinical operation, baseline information should be
re-evaluated and X-ray equipment performance should be examined.
The more technical evaluation should be performed by a medical
physicist or individual specialized in mammographic X-ray equipment
testing and evaluation.
- Mammographic X-ray equipment - Initially, equipment performance
must be fully evaluated. The equipment should be
assessed for compliance with the requirements in Section 5.3.
Not all the tests need to be repeated on an annual or semi-annual
basis since equipment performance for some components is not
likely to change during clinical operation. However, if a
component is serviced or replaced, in such a way that performance
may be changed, the performance must be
re-evaluated. Initial technical evaluation is presented below;
Section 8.2.1 presents tests which need to be performed on an
annual or semi-annual basis.
X-ray generation
a. X-ray beam filtration and radiation beam quality
b. X-ray tube voltage accuracy and reproducibility
c. Irradiation timer accuracy and reproducibility
d. Reproducibility of radiation output
e. Focal spot size
Beam limiting device
f. Proper radiation beam alignment
g. Light field/X-ray image receptor congruence
Ancillary components
h. Source to image receptor distance indicators accuracy
i. Compression device design and performance
j. Bucky system and grid performance
Other
k. Stability of equipment
l. Mechanical and electrical performance
m. Inspection and replacement ofworn or broken components
n. Manufacturer's maintenance schedule
- Automatic Exposure Control system - Initially, Automatic
Exposure Control system performance must be fully evaluated
for compliance with the requirements in Section 5.3.1, No. 7,
for film-screen X-ray mammographic X-ray equipment, or
Section 5.3.2, No. 7, for Xeromammographic X-ray equipment
and baseline values established. Tests performed during initial
evaluation of the system are presented below. Section 8.2.1
presents tests which need to be performed on a semi-annual
basis.
a. Reproducibility
b. X-ray tube voltage compensation
c. Minimum response time
d. Thickness compensation response
e. Optical Density setting response
f. Backup timer
- Films, screens and cassettes - For film-screen X-ray mammography,
initially, there must be an evaluation of the
appropriateness of the film-screen combination being used. This
evaluation should be done each time a new type of film or screen
is being introduced. Initial evaluation is presented below;
Section 8.2.1 presents tests which need to be performed on an
annual or semi-annual basis.
a. Adequacy of film-screen combination
b. Film-screen speed uniformity
c. Film-screen contact
d. Screen condition
- Image processing - The initial evaluation of image processing
involves the adequacy of the darkroom environment, and the
establishment of baseline values required during Quality Control
monitoring. Initial evaluation is presented below.
Darkroom
a. Light tightness
b. Safelight conditions
c. Cleanliness
d. Temperature control of water supply
e. Ventilation system
f. Fixer recovery system
Film Processing
g. Condition of processing equipment
h. Film speed and contrast
i. Level of film base plus fog
j. Solution temperature
k. Replenishment rate
l. Fixer retention analysis
m. Posting of maintenance schedule and Quality Control test
results
Xeromammographic processing
n. Condition of processing equipment
o. Selenium plate defects
p. Posting of maintenance schedule and Quality Control test
results
- Viewboxes - The evaluation of performance of all viewboxes
used for mammograms examination must be done on an annual
basis. Initial evaluation is presented below; Section 8.2.1
presents tests performed on an annual basis.
a. Viewbox surface conditions
b. Brightness
c. Light output homogeneity between viewboxes
d. Light output uniformity
e. Image masking
f. Ambient light control
- Imaging characteristics - The imaging performance of the
mammographic X-ray system must be assessed along with the
establishment of representative patient dose values. A phantom,
with image quality evaluation objects, should be used to test
overall performance of the mammographic X-ray system by a
quantitative evaluation of the system's ability to image small
structures such as fibres, specks and masses, at similar
dimensions to those found clinically. The results of phantom
image evaluations can therefore be used to establish a baseline
value for the Quality Control monitoring program. Another
phantom representing compressed breast tissue should be used
to measure breast surface dose to calculate the mean glandular
dose. The tests for the initial evaluation are presented below and
in Section 8.2.1.
a. Representative breast surface doses with mean glandular
dose calculations
b. Image spatial resolution
c. Image contrast
d. Image quality
8.2.1 Description and frequency of tests
Table 5 presents suggested performance criteria and recommended
frequency of testing for mammographic X-ray equipment. It
must be noted that some facilities may require a different frequency
of testing than suggested and that for facilities under provincial
jurisdiction, different performance criteria and testing frequency
may apply.
Table 5: Description and frequency of tests
| Test |
Performance Criteria |
Frequency |
| Mammographic X-ray equipment |
| Focal spot size |
Section 5.3.1 No. 2 or |
Annually |
| |
Section 5.3.2 No. 2 |
|
| Beam limiting device |
Section 5.3 No. 9 |
Annually |
| Compression plate alignment |
Section 5.3 No. 11 |
Annually |
| Radiation output |
Section 5.3.1 No. 6 or Section 5.3.2 No. 6 |
Semi -annually |
| X-ray timer |
Section 5.3 No. 7 |
Semi-annually |
| Backup timer |
Section 5.3 No. 7 |
Semi-annually |
| X-ray tube voltage |
Section 5.3.1 No. 5 or Section 5.3.2 No. 5 |
Semi-annually |
| Radiation beam quality |
Section 5.3.1 No. 4 or Section 5.3.2 No. 4 |
Semi-annually |
| Automatic Exposure Control system |
| Optical density setting response |
Section 5.3.1 No. 7 or Section 5.3.2 No. 7 |
Semi-annually |
| X-ray tube |
Section 5.3.1 No. 7 or |
Semi-annually |
| voltage compensation |
Section 5.3.2 No. 7 |
|
| Thickness |
Section 5.3.1 No. 7 or |
Semi-annually |
| compensation response |
Section 5.3.2 No. 7 |
|
| Films, screens and cassettes |
| Screen/film speed uniformity |
Section 6.5 |
Semi-annually |
| Viewboxes |
| Brightness |
Section 6.4 |
Annually |
| Light output uniformity |
Section 6.4 |
Annually |
| Light output |
Section 6.4 |
Annually |
| homogeneity |
|
|
| Ambient light control |
Section 6.4 |
Annually |
| Imaging characteristics |
| Representative breast surface dose and meanglandular dose calculations |
Appendix II |
Annually |
| Image spatial resolution |
Baseline |
Annually |
| Image contrast |
Baseline |
Annually |
| Image quality |
Baseline |
Annually |
8.3 Quality Control monitoring
Quality Control procedures to be performed in a Quality Assurance
program are presented in the following list. Section 8.3.1 presents
the tests with the suggested frequency and performance criteria.
- Mammographic X-ray equipment - Mammographic X-ray
equipment should be checked for loose or broken components.
Breast compression force should be checked.
- Darkroom and image processing operation - There should be
regular inspection of darkroom and processing equipment for
cleanliness. Light-tightness and correct safelighting should also
be assessed on a regular basis. The accuracy of the processor
thermometer used should be checked. A daily inspection of film
processing solutions levels, and cleanliness of darkroom should
be made.
- Film, screen and cassette - Screens should be checked for
cleanliness and damage. Cassettes should be checked for cleanliness,
wear, warping, fatigue of foam compression material and
closure mechanism, light leaks, and film-screen contact. The
cassette holder tunnel should be checked for dust and dirt.
- Viewboxes - Viewboxes should be checked for cleanliness,
viewing area discoloration and improper illumination.
- Image characteristics - Test images are needed to monitor the
performance of the mammographic X-ray system and image
processing. A phantom representing breast thickness should be
routinely used to monitor and maintain image density. Another
phantom, with image quality evaluation objects, should also be
used to test imaging performance of the mammographic X-ray
system. The image Quality Control monitoring tests and
evaluations must be performed on a regular basis.
- Retake record - A record of every retake should be made,
including the reason for the retake along with any corrective
actions. If images contains some patient diagnostic information,
they should be maintained in the patient file. Any trends or
repeated errors should be identified and corrected.
8.3.1 Description and frequency of tests
Table 6 presents suggested performance criteria and
recom-mended frequency of testing for mammographic Quality
Control. It must be noted that some facilities may require a different
frequency of testing than suggested and that for facilities under
provincial jurisdiction, different performance criteria and testing
frequency may apply.
Table 6: Description and frequency of tests
| Test |
Performance Criteria |
Frequency |
| Mammographic X-ray equipment |
Breast compression
device force |
Section 5.3 No. 11 |
Semi-annually |
X-ray equipment
conditions |
Visual acceptance |
Monthly |
| Darkroom and image processing operation |
| Level of film base plus fog |
Section 6.3 |
Semi-annually |
| Safelight test for darkroom fog |
Section 6.2 |
Semi-annually |
| Fixer retention in film |
Baseline |
Quarterly |
| Thermometer accuracy |
Section 6.1 |
Monthly |
| Darkroom conditions |
Visual acceptance |
Daily |
| Replenishment rate |
Baseline |
Daily |
| Film processing solution levels |
Baseline |
Daily |
| Film processing solution temperature |
Baseline |
Daily |
| Sensitometric strip processing |
Baseline |
Daily |
| Films, screens and cassettes |
| Screen/film contact |
Section 6.5 |
Semi-annually |
| Screen conditions |
Section 6.5 |
Weekly |
| Viewboxes |
| Viewboxes conditions |
Visual acceptance |
Weekly |
| Image characteristics |
| Image contrast |
Baseline |
Weekly |
| Image quality |
Baseline |
Weekly |
| Image density |
Baseline |
Daily |
| Retake record |
| Retake analysis |
Baseline |
Monthly |