New FDA Mammography Act Requires Facilities to Provide Written Results to Patients within 30 days
As of April 28, 1999, all women who have mammograms must be informed of the results in writing, under the U.S. Food and Drug Administration (FDA) Mammography Quality Standards Reauthorization Act of 1998. This provision has been added to the final regulations that implement the Mammography Quality Standards Act (MQSA) of 1992.
The FDA notes in a statement that many institutions already provide this service, but the FDA ruling "ensures that written notification occurs promptly, in easy-to-understand language, and that it is provided by every mammography facility in the United States."
FDA Commissioner Dr. Jane E. Henney, an oncologist, commented that "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."
The FDA Mammography Quality Standards Reauthorization Act is in response to reports of suspicious findings on mammography that were not reported to the patient, resulting in a delay in diagnosis of breast cancer. Previously, accredited mammography centers were only required to provide a written report to a woman's doctor.
To further aid diagnosis, the regulations also require mammography facilities to send original mammograms, not copies, to a patient or a patient's physician on request, so that they may be compared to previous mammograms.
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.
The FDA press release announcing the Act may be viewed at http://www.fda.gov/bbs/topics/NEWS/NEW00679.asp
The locations of certified mammography facilities are available by calling the Cancer Information Service at 1-800-4-CANCER (1.800.422.6237, sponsored by the National Cancer Institute) or by visiting the online Mammography Site Database at The Center for Devices and Radiological Health website (maintained by the FDA) at www.fda.gov/scripts/cdrh/cfdocs/cfmqsa/search.cfm.