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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Automatic Densitometers and Saving Data

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Issue:

Inspectors are finding situations in which individuals that monitor processor performance with an automatic densitometer are on occasion forgetting to press the "save" button. As a result, when they print out their processor charts later, there are gaps in those charts.

Policy:

This would be an inspection observation just as is the case when an individual doing the test manually forgets to record the data on the chart, unless the facility had recorded the density on another form or on the film. If the facility has no record that the test was done on that day, the facility has no evidence that the test was done and the inspector should cited this. The level of the observation would depend upon how often the facility did not save the required data.