Mammogram imaging at Tampa Bay area radiology facility did not meet FDA standards

HUDSON, Fla. — A Spring Hill woman is worried about the results of her most recent mammogram after she received a letter that says the imaging from that test didn’t meet FDA standards. 

Jean White says she's gotten an annual mammogram from Radiology Associates in Hudson for twenty years. Her most recent was in April and the results were normal.

"Oh thank God you know because I really sweat that test,” she said.

But for the second time this year, she will pay out of pocket for another test done at another facility. Her insurance only covers one a year. 

"I go tomorrow for a mammo and I’m kind of nervous about it,” she said. 

She received a letter from Radiology Associates that there is “Serious concern about the quality of the mammography our facility performed between March 7, 2016 and March 7, 2018.”

In April, the American College of Radiology asked for randomly selected mammography cases from the facility.

In June, the mammography practice was shut down and the accreditation was pulled because experts say it did not meet FDA image quality standards. 

The letter goes on to say, "This does not necessarily mean that the results you and your healthcare provider were given are wrong. However, most patients will need to have their mammogram(s) performed at our facility reviewed to determine whether a repeat mammogram at another facility is needed."

"The faster you find it you’re better off,” White said. "But what happens if I had something in 2016?"

Jean has fibrocystic breast disease, which requires extra attention. She worries a new doctor will not have anything to compare to.

"How are they going to say well your x-ray looks good from your last one you know what I mean, it just upsets me, it does. It just upsets me,” White said. 

Radiology Associates did not want to talk on camera but tells ABC Action News it is working quickly to get additional training for radiologists and technologists on positioning and compression techniques. Once that training is complete it will reapply for accreditation. 

You can check to see if a facility is accredited by typing in the business' ZIP Code on the FDA’s website.

You can also find out if a facility has ever lost its accreditation by clicking here.

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