The FDA issued a notice concerning mammogram quality at Boston Diagnostic Imaging in Orlando, Florida. The facility failed its accreditation renewal and a subsequent investigation by the American College of Radiology brought quality issues to light. The facility has also lost its MQSA certification and can no longer legally provide mammograms in the U.S. If you or a loved one had a mammogram done there on or after May 13, 2013, you should consult your doctor as you may possible need a repeat mammogram. NOTE: This does not mean your mammogram results were wrong!
The FDA issued mammogram quality safety notice today for all patients who had mammograms performed by Boston Diagnostic Imaging in Orlando, Florida on of after May 13, 2013. The notice is also for all health care providers who sent patients to Boston Diagnostic Imaging in that same time frame.
Please NOTE: This notice does not mean that the mammogram results were wrong. It is regarding the quality of the mammograms, as they do not measure up to accepted quality standards.
While mammography (a safe, low-dose X-ray of breast tissue) is currently one of the most effective methods of finding breast cancer in the early, treatable stages, the mammograms done by Boston Diagnostic Imaging may not have been done properly.
After the facility’s accreditation renewal, the American College of Radiology (ACR) examined a series of mammograms done there between May 13, 2013 and May 13, 2015. This review was a follow-up based on deficiencies noticed during the accreditation renewal. After the examination, ACR revoked Boston Diagnostic’s MQSA certificate, effective August 13, 2015. The ACR further ordered the facility to stop performing mammograms.
The Mammography Quality Standards Act of 1992 (MQSA) gives the FDA the authority to require all mammography facilities to meet certain quality standards, as well as certification to legally provide mammograms in the U.S. Boston Diagnostic Imaging can no longer legally provide mammograms because its MQSA certificate was suspended.
Again, this does not imply that your mammogram results were wrong if you went to Boston Diagnostic on or after May 13, 2013. It means that the quality of the procedure may have been poor and you may want to have your films re-evaluated by an MWSA-certified facility. This review will tell you if you need to have another mammogram done due to poor quality or if you need other medical follow-up.
Patients have the right to their mammogram films and copies of the results and other medical reports.
The Boston Diagnostic Imaging facility is the one at 1751 S. Orange Avenue in Orlando, Florida. The FDA issued a notice to Boston Diagnostic Imaging on August 13, 2015 that required the facility to notify all patients who had mammograms done during the affected time period. The notice further required Boston Diagnostic to notify the referring health care providers.
- If your most recent mammogram was done at an MQSA-certified facility after the one you had done at Boston Diagnostic, follow the advice of that facility.
- If your most recent mammogram was done at Boston Diagnostic, you should do the following:
- Speak with your primary health care provider ASAP about possible follow-up, such as a re-evaluation of your mammogram, a repeat mammogram or other medical evaluation.
- If you need a repeat mammogram, get it done at an MQSA-certified facility. You can find one using this database or by calling the National Cancer Institute (NCI) information line at 1-800-422-6237.
- If your health insurance will not pay for a repeat mammogram, call the NCI information line at 1-800-422-6237. The NCI staff may be able to find a facility near you that will do it free or at low-cost.
The FDA is monitoring the issue and will keep the public informed if/when new information becomes available.
You can call the MQSA Hotline with questions at 1-800-838-7715 or email MQSAhotline@hcmsllc.com. You can also fax them your question at 1-410-290-6351.
I understand you may be frightened by this announcement. Please try to remember that this does not mean bad news. It’s a safety precaution only. I strongly urge you to follow the FDA recommendations if you had your mammogram done at Boston Diagnostic Imaging on or after May 13, 2013. Do it for yourself; do it for your loved ones. Do it for peace of mind.