900.12(e)(1)(i),(ii),(iii): Daily quality control tests. Film processors used to develop mammograms shall be adjusted and maintained to meet the technical development specifications for the mammography film in use. A processor performance test shall be performed on each day that clinical films are processed before any clinical films are processed that day. The test shall include an assessment of base plus fog density, mid-density, and density difference, using the mammography film used clinically at the facility.
(i) The base plus fog density shall be within +0. 03 of the established operating level.
(ii) The mid-density shall be within ±0.15 of the established operating level.
(iii) The density difference shall be within ±0.15 of the established operating level.
Approved Alternative Standard:
- Is an intermittently used processor (so called back-up processor) held to the same QC standards as the primary mammography processor?
- What about QC on mammography processors that are also used to develop films for copying mammograms and for laser films that are used in digital mammography?
- Must a facility perform the daily processor QC tests on days when mammograms are performed but not processed?
- We have a separate processor that we only use to make mammography copies. Are there any MQSA requirements that this processor has to meet?
- We are sending our densitometer out for a regularly scheduled calibration. While it is gone, how can we continue with our daily quality control program until it is returned? Can we use a "loaner" densitometer or perform some substitute test in the interim?
- Must all facilities use 5 days to establish operating levels in a processor or can they use a longer period?
- In which situations should facilities establish new processor operating levels?
- During the time a facility is establishing new processor operating levels (typically done by performing a five-day data plot average): A) does the facility continue to plot the data on the processor chart?; B) Is the facility exempt from having to stay within the old processor action limits during the five-day averaging period?