by John R. Fischer
, Senior Reporter | February 07, 2018
A Florida medical imaging center's doors are now closed after failing to meet the appropriate standards in mammogram performance set out by the American College of Radiation.
The FDA is urging patients who underwent mammograms at Palm Beach Broward Medical Imaging Center, also known as Radiology Express in Deerfield, since April 2016, to speak with their providers about additional screening and reevaluation of exams, following an investigation that found issues in the quality of mammograms performed there, leading to the eventual revocation of its accreditation for failing to meet ACR clinical image evaluation criteria.
“The FDA is alerting patients who had mammograms at Palm Beach Broward Medical Imaging Center located in Deerfield Beach, Florida, on or after April 2, 2016, about possible problems with the quality of their mammograms,” Stephanie Caccomo, an FDA press officer, told HCB News. “This does not mean the results of the mammograms were inaccurate, but it does mean that health care providers and patients should consider having these mammograms reevaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if a repeat mammogram or additional medical follow-up is needed. A lack of quality mammography can lead to missed cancers.”
Mammography facilities throughout the U.S. are required to meet certain baseline quality standards and be certified under the FDA in accordance with the Mammography Quality Standards Act of 1992.
The dismissal of the center’s accreditation as well as the FDA’s issuance of a “no longer in effect” status for its MQSA certificate stems from a February, 2017 inspection which found a halt in performance of the manufacturer's recommended quality control tests after April 1, 2016.
The facility then underwent an Additional Mammography Review (AMR), overseen by the ACR, with the quality of its exams failing to measure up to appropriate standards.
Palm Beach Broward Medical Imaging Center is prohibited from performing any more mammograms, and has been directed by the FDA to notify patients and their providers about the problems with their mammography quality.
“They have not yet notified patients,” said Caccomo, as of February 2018.
Those who have undergone recent mammograms at other MQSA-certified facilities are encouraged to abide by their guidelines. Those who have not are urged to speak to their providers about reevaluation of exams, repeat mammograms and possible further evaluation.
The FDA is continuing to monitor the situation.
Palm Beach Broward Medical Imaging Center could not be reached for comment.