FDA clarifies how long mammograms must be retained

In a January 5 update posted on its site, the U.S. Food and Drug Administration (FDA) clarified how long breast imaging facilities should keep original mammograms and their reports.

The Mammography Quality Standards Act (MQSA) requirement states that a facility must "maintain mammography films and reports in a permanent medical record of the patient for a period of not less than five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility, or a longer period if mandated by state or local law." This requirement has been confusing to some facilities, according to the FDA, so it offered this clarification:

At a minimum, each mammogram must be retained for at least five years. If a patient has returned to the facility within those five years for one or more subsequent mammograms, only the most recent five years' worth of exams must be retained. If a patient has not returned for another mammogram at the facility within five years of her most recent exam performed there, the facility cannot know when she might return for another exam (or might request her exams), so her mammograms must be retained for up to five additional years (10 years in total) in case she returns or makes such a request.

States may impose stricter requirements for medical record retention, the FDA noted. In addition, there is no difference in the required length of time for retaining digital mammograms compared to film-screen exams.

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