[U.S. Food and Drug Administration]

FDA Medical Bulletin * Summer 1997 * Volume 27 Number 2

REMINDER FOR PHYSICIANS
INTERPRETING MAMMOGRAMS

FDA is reminding physicians interpreting mammograms that they must document in a simple, organ-ized manner all mammograms that they have interpreted. This documentation is necessary to meet the continuing experience requirements under the Mammography Quality Standards Act (MQSA). This aspect of the requirements became effective October 1, 1996.

When MQSA inspectors visit a mammography facility, they will check to see that the interpreting physician has met the requirement to interpret an average of at least 40 mammograms per month over a 24- month period. Failure to have adequate documentation will jeop- ardize a physician's eligibility to interpret mammograms, as well as subject the facility to a finding of noncompliance at the time of inspection. Since physicians may combine totals from different facilities for which they have interpreted mammograms in order to satisfy the requirement, each physician must keep his or her own records of interpreting activity. Physicians may document records by obtaining a letter from each facility, signed by the facility official, stating that the physician has interpreted a given number of mammograms at that facility during a given time period, preferably broken down by month. Alternatively, the physician could enter into a journal, file, or log the patient name, number, comments, name of facility, and date on which the mammogram was read. For further information, call the Mammography Quality Assurance Program, telephone 1-(800) 838-7715; fax (410) 290-6351.

REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO MEDWATCH
1-800-FDA-1088

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