Date Issued: August 26, 2021

The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Madison Avenue Radiology Center 190th Broadway, located in New York, New York, on or after February 26, 2019, about possible problems with the quality of their mammograms.

Recommendations for Patients

• If you have had a more recent mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after February 26, 2019, follow the recommendations from that facility.
• If you have not had a mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after February 26, 2019, follow these guidelines:
  • Consider asking for your mammogram and copies of your medical reports from Madison Avenue Radiology Center 190th Broadway, and have your mammogram reviewed at a MQSA-certified facility to decide if a repeat mammogram or more medical follow-up is needed. As a patient, you or your representatives have the right to ask for your mammograms and copies of your medical reports.
  • A database of Mammography Quality Standards Act (MQSA)-certified facilities can be found online, or you can call the National Cancer Institute's information telephone number at 1-800-422-6237 to find a MQSA-certified facility in your area.

Device Description

A mammogram is a safe, low-dose, X-ray picture of the breast. It is currently the most effective primary screening method for detecting breast cancer in its earliest, most treatable stages.

Summary of Problem or Scope

The FDA became aware of problems associated with the quality of mammograms performed at:

Madison Avenue Radiology Center 190th Broadway
4448 Broadway
New York, New York 10040

The facility’s annual MQSA inspection revealed violations and the facility failed to demonstrate that it was meeting the requirements of the Enhancing Quality Using Inspection Program (EQUIP) initiative. Specifically, the facility failed to meet the requirements of EQUIP because it did not have a system in place to ensure clinical images continue to comply with the standards for clinical image quality established by the facility’s accreditation body, the American College of Radiology (ACR) because there is no mechanism in place for regular reviews of image quality attributes of sample mammograms performed for each active radiologic technologist (RT) and a sample of mammograms accepted for interpretation for each active interpreting physician (IP), and there is no documentation of review since the facility’s last MQSA inspection.

As a result, the FDA notified the facility 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 the facility to operate in compliance with the MQSA, and whether there was a need to notify affected patients.

The ACR conducted the AMR of mammograms performed by Madison Avenue Radiology Center 190th Broadway, and the results indicated the mammograms did not meet the ACR’s clinical image evaluation criteria, and some of the deficiencies were severe. On July 8, 2021, the ACR revoked the facility’s accreditation, and on July 9, 2021, the FDA placed the facility’s MQSA certificate in a “no longer in effect” status.

On July 13, 2021, the FDA directed the facility’s owner to notify all patients who received mammograms at Madison Avenue Radiology Center 190th Broadway, on or after February 26, 2019, and their referring healthcare providers, about the problems with the mammography quality at the facility. To date, the facility has not performed the ordered notifications.

Under the MQSA, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet the standards for mammography quality under the MQSA. This facility may not legally perform mammography at this time, as it does not have an active MQSA certificate.

FDA Activities

The FDA will continue to monitor this issue and keep the public informed as new information becomes available. At this time, the FDA recommends that patients contact Madison Avenue Radiology Center 190th Broadway, to gain access to their medical records and follow the Recommendations for Patients above.

Contact Information

If you have questions about this communication, please contact the Mammography Quality Standards Act Hotline by phone: 1-800-838-7715, email: [email protected] or fax: 1-443-285-0689.