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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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. Mammographic X-ray equipment - Mammographic X-ray equipment should be checked for loose or broken components. Breast compression force should be checked.
  2. 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.
  3. 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.
  4. Viewboxes - Viewboxes should be checked for cleanliness, viewing area discoloration and improper illumination.
  5. 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.
  6. 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