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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Situations That Do Not Have Corresponding Questions in the Software

Policy Guidance Help System logoThe following policy pertains to situations where inspectors have found problems that should be brought to the attention of facility personnel, but do not have a specific question in the inspection software:

  • Phantom image artifacts (other than fibers, specks, or masses)

  • Dirty viewbox, or dirty conveyor for batch-viewing of mammograms

  • Dirty darkroom or dirty screens.

None of these situations (and there may be others) have direct questions with simple answers in the software program, but yet each can pose a reporting dilemma for the inspector when he or she feels that the case in question affects mammographic quality to the point where the facility should be cited for it.

Whenever possible, the questions in the software program were designed to eliminate subjective answers and minimize the number of cases where a judgment call has to be made on the part of the inspector. While this is a straightforward process for most of the physical tests, some (like phantom image scoring and artifact subtraction) are still somewhat subjective. On the other hand, identifying artifacts due to processor roller marks, or the cleanliness of a viewbox or a darkroom, is not so easily and uniformly done.

Inspectors should use the following approach:

  1. Phantom image artifacts. If the artifacts are objectionable to the point that it affects the visibility of any of the phantom objects appreciably, the score of the object in question should be adjusted appropriately, even though this artifact is not one of those normally counted in phantom scoring. Also, document your findings about this in the printable Remarks field for the 3.5.3 Phantom Image Quality Evaluation screen and advise the facility about the problem. If the artifacts in question are objectionable enough but do not affect the visibility of any of the phantom objects, document your findings about this in the printable Remarks field and advise the facility about the problem.
  2. Dirty viewbox, or dirty conveyor for batch-viewing of mammograms. Inspectors should document you’re their findings about this in the printable Remarks field in the 3.9 Quality Control screen and advise the facility about the problem.
  3. Dirty darkroom or dirty screens. Again, the inspector should document their findings about this in the printable Remarks field in the 3.9 Quality Control screen and advise the facility about the problem. In addition to that, if excessive dust and dirt is the problem, it is likely to affect the phantom image score.
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