The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Advanced Women’s Imaging (AWI), located at 560 60th Street in Guttenberg (also known as West New York), New Jersey since March 11, 2020 about possible problems with the quality of their mammograms.
Under the Mammography Quality Standards Act (MQSA), the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. The annual MQSA inspection of AWI indicated that required quality control tests were not performed.
As a result, the FDA notified AWI that it was required to undergo an Additional Mammography Review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of AWI to operate in compliance with the MQSA, and whether there was a need to notify affected patients.
The American College of Radiology (ACR), at the request of the FDA, contacted AWI to request the clinical images and documentation needed to conduct the reviews of mammograms performed at Advanced Women’s Imaging. The facility did not comply with the ACR’s request.
On September 12, 2020, the MQSA accreditation of Advanced Women’s Imaging (AWI) expired. On September 15, 2020, the U.S. Food and Drug Administration (FDA) notified AWI that it was no longer legally certified for, and must cease performing, mammography.
Patients or their representatives have the right to ask for copies of their mammograms and medical reports. Patients who had a mammogram at AWI after March 11 2020 and have not had a mammogram at a different MQSA-certified facility since then should consider asking AWI for copies of their mammograms and medical reports and have them reviewed at another MQSA-certified facility.
A database of Mammography Quality Standards Act (MQSA)-certified facilities can be found online,. You can also call the National Cancer Institute information telephone number at 1-800-422-6237 to find a MQSA-certified facility in your area.