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April 27, 1999
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This provision has been added to the final regulations that implement the Mammography Quality Standards Act (MQSA) of 1992 and that go into effect April 28. The new provision reflects improvements in the law made by the Mammography Quality Standards Reauthorization Act of 1998.
Although many mammography facilities already provide this service, the FDA rule ensures that written notification occurs promptly, in easy-to-understand language, and that it is provided by every mammography facility in the United States.
"Mammography is the best tool we have to prevent breast cancer, and having written results in clear language will reinforce the importance of this examination," said Health and Human Services Secretary Donna E. Shalala. "No woman should be in the dark about the results of her mammogram, and thanks to this rule, she won't be."
"Our agency has worked long and hard over the past several years to ensure that American women can depend on receiving high quality mammography screening for breast cancer," said FDA Commissioner Jane E. Henney, M.D. "As an oncologist, I know how important it is for women's health to have accurate mammograms with the results reported promptly to the woman and her physician."
Facilities performing mammograms will continue to report results directly to the patient's physician. But they will now provide patients with a separate, easy-to-understand summary report within 30 days. Self-referred patients with no designated healthcare provider will receive both the simplified report and the one doctors normally receive.
If the results are suspicious or suggest cancer, they must be communicated to the patient as soon as possible, ordinarily within five working days. If the results are unclear or incomplete, the FDA recommends that facilities communicate this to patients as soon as possible to avoid delays in follow up care. The exact language of the report and the system for reporting are left up to the facility.
The new notification requirement is a response to anecdotal reports of "suspicious" mammograms not being reported to patients, resulting in breast cancer going undetected until too late.
The final regulations also require mammography facilities to transfer original, as opposed to copies of, mammograms to a patient's physician or to the patient on request. This aids diagnosis by allowing doctors to compare old mammograms with new ones.
Under MQSA, all mammography facilities in the United States must now meet certain stringent standards for equipment, personnel and image quality, be accredited by an FDA-approved accreditation body, be MQSA-certified, and be inspected annually.
Today virtually all 10,000 facilities have fully met standards and are certified to perform mammography. The names and locations of certified mammography facilities are available by calling the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237), or on FDA's Website at www.fda.gov/cdrh/faclist.html.