All it took was a stern FDA warning letter to the MRI Imaging Specialist clinic — with threats of $11,000-per-day fines and a possible shutdown — to get the Norcross, Ga., mammography center to focus on potentially life-threatening problems raised multiple times over the last few years.

"Two previous non-compliant MQSA [Mammography Quality Standards Act of 1992] inspections on July 1, 2014 and June 17, 2015," had identified eight violations — the most serious being, stated the Atlanta Journal Constitution, that the clinic had including an inadequate system to provide lay summaries to patients.

Other problems included failure to enter all positive mammograms into the tracking system, and contrast-to-noise quality testing that was inadequate in some cases, inadequate medical auditing, as well as other issues, according to the FDA's Atlanta district office communication.
The letter noted that, despite repeated warnings about these problems over the past two years its most recent follow-up inspection in February, "revealed continuing serious problems involving the conduct of mammography at your facility."

“Because the continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions,” the letter says.

The Jimmy Carter Boulevard facility and its listed owner Miguel Leon had just 15 days to respond. Clinic spokesman Michael Alatorre told WXIA news that, “We’ve been trying to make sure that we get all the issues resolved,” and that the clinic is now in compliance.

“It is very serious, but it’s nothing that we’re worried about,” Alatorre said, adding,"We have complied with everything."

At present, the FDA has not responded to questions from WXIA about any decisions concerning what the clinic has done to resolve its issues.

The FDA wake-up call had led the facility to address the concerns, he stressed, adding that, “These machines are very, very delicate. And every little thing will set it off. And it doesn't matter how many times you try to get the quality back in by putting on engineers and spending a lot of money, and trying to get it resolved.”

The clinic spokesman stressed that his firm's main concern is "just for our patients, and our quality that we give to our patients."

FDA MQSA requirements include that, "each facility must have a system to track positive mammograms and a process to correlate the findings with biopsy results. Positive mammograms are those with final assessment categories of 'Suspicious' or 'Highly suggestive of malignancy,'" according to the agency's guidance system.

It must also have an adequate medical outcomes audit system for the site as a whole, and for each individual at the site, which the letter stated the the clinic had not done, nor done annually.

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