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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Adverse Event

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Citation:

900.2(c) Adverse event means an undesirable experience associated with mammography activities within the scope of 42 U.S.C. 263b. Adverse events include but are not limited to:

(1)  Poor image quality

(2) Failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and

(3)  Use of personnel that do not meet the applicable requirements of section 900.12(a).