Mammograms performed at Boston Diagnostic Imaging in Orlando may have problems with quality if they were conducted on or after May 13, 2013, the U.S. Food and Drug Administration (FDA ) warned. According to the safety alert posted on the agency’s website, patients who had a mammogram during this period should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if another mammogram or additional follow-up is necessary; the results at Boston Diagnostic Imaging are not necessarily inaccurate.
On August 13th, the FDA told the facility to notify all affected patients about the quality issues. In order for a mammography facility to operate legally in the United States, it must meet baseline quality standards under the MQSA of 1992. Boston Diagnostic Imaging “did not meet standards for mammography quality under the Act. The facility may no longer legally perform mammography at this time due to the suspension of its MQSA certificate.” the FDA alert stated. The FDA suspended the facility’s MQSA certificate on August 13th and also ordered Boston Diagnostic Imaging to stop performing mammography.
The problems were detected when the American College of Radiology (ACR) found issues with clinical cases submitted with the facility’s renewal application. The ACR subsequently conducted a clinical review between May 13, 2013 and May 13, 2015. On July 29, 2015, the ACR revoked the facility’s mammography accrediation.