900.12(d): Quality Assurance — general. Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the facility.
- Why hasn't FDA specified the protocols for performing QC tests?
- How often must the densitometer and sensitometer be calibrated?
- When performing a physics survey or equipment evaluation on a unit with multiple target/filter combinations, what tests or measurements must be performed for each combination?
- I have been following the ACR manual and have used an optical density range of 0.7-0.8 when doing my screen-film contact test. The film manufacturer recommends that I use a higher optical density. What should I use under the final regulations?
- If there are several acceptable methods for testing performance of a QC requirement and the item being tested passes by one, but not all, the methods, does the item still meet the requirement?
- A facility is using more than one type of screen-film combination. Must it perform the QC tests separately for each combination used?
- How should facilities document performance of the required QC tests to comply with the regulations?
- Our facility has multiple mammographic units and uses several different screen-film combinations. What QC tests are we required to perform?