FDA: Quality problems with mammograms at Orlando facility
ORLANDO, Fla. (WOFL FOX 35) - The U.S. Food and Drug Administration has sent out an alert warning of "quality problems" with mammograms performed at Boston Diagnostic Imaging in Orlando.
The mammograms in question were performed anytime on or after May 13, 2013 at the Boston Diagnostic Imaging facility at 1751 S. Orange Avenue in Orlando.
According to the FDA, the facility's Mammography Quality Standards Act (MQSA) certificate was suspended on August 13, 2015.
The FDA directed the facility to cease performing mammography.
According to the FDA, this does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at a MQSA-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up.
RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Boston Diagnostic Imaging on South Orange Avenue in Orlando any time on or after May 13, 2013:
- If you have had a more recent mammogram at a MQSA-certified facility since then, you should follow the recommendations from that facility.
- If you have not had a mammogram at an MQSA-certified facility since then, follow these guidelines:
- Talk with your health care provider as soon as possible about your medical follow-up. You may need your mammogram re-evaluated, and possibly need a repeat mammogram and/or possible further evaluation.
- If your health care provider recommends a repeat mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy. A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute's (NCI) information number at 1-800-422-6237.
- If you need a repeat mammogram and your health insurance will not pay for it, you can call the National Cancer Institute's (NCI) information number at 1-800-422-6237. Experts at this number may be able to identify a facility near you that provides free or low-cost mammograms.
Orlando Health released this statement:
"Our focus is on the well-being of the patients impacted by this. We are contacting each patient and their physician with additional information and instructions to guarantee that each patient will receive repeat imaging. This mammography quality concern was confined to the Orlando Boston Diagnostic Imaging facility on Orange Avenue and impacts only the mammography program there. All other services there remain fully accredited, and all imaging services at the four other Boston Diagnostic facilities are also fully accredited and operating. As partial owners of the facility since December 2014, we realize that we inherited the majority of deficiencies identified by regulators. Nevertheless, we are committed to making this right for all patients involved, and at no cost to them. We are cooperating with the American College of Radiology and the Food and Drug Administration and will resume the mammography program at the Orlando facility on Orange Avenue only when we are certain the services can be delivered consistently at the highest quality."