Mammography quality violations and sub-par standards have forced the U.S. Food & Drug Administration to revoke one New York imaging center’s breast screening credentials.
Madison Avenue Radiology Center’s annual Mammography Quality Standards Act inspection revealed the facility, located at 4448 Broadway, did not have a system in place to ensure images comply with standards set by the American College of Radiology.
Notably, the FDA said there was no mechanism to review sample mammograms for each active radiologic technologist nor interpreting physician. The center also lacked documentation since its last MQSA inspection, the administration said in an Aug. 26 warning.
After performing an Additional Mammography Review, the ACR found larger quality problems with the center’s mammograms, including some “severe” deficiencies. The college subsequently revoked the New York center’s accreditation on July 8 and the FDA designated its MQSA certificate as no longer in effect the following day.
“This facility did not meet the standards for mammography quality under the MQSA,” the FDA said Thursday. “This facility may not legally perform mammography at this time, as it does not have an active MQSA certificate.”
Furthermore, the site’s owner has failed to notify all patients who underwent a mammogram from Feb. 26, 2019, and beyond, along with patients’ referring healthcare providers. The FDA made the request on July 13.
“The FDA will continue to monitor this issue and keep the public informed as new information becomes available,” the health oversight organization wrote, adding it encourages patients to contact Madison Avenue Radiology Center to obtain their medical records.
Read the full update here.