Belleville Imaging, a radiology center, has lost its mammography certification after an accrediting agency found in a review that some of its examinations did not match clinical standards.
The American College of Radiology, which reviewed 30 examinations between May 13, 2014, and Aug. 31 of this year, found problems with both how the images were taken and how they were read.
A manager for Belleville Imaging said the mammograms aren’t necessarily wrong. The radiology group that reads mammograms for Belleville Imaging declined comment.
The ACR noted that 18 images “did not meet the ACR’s clinical image evaluation criteria,” wrote Jean M. Weigert, chair of the Committee on Mammography Accreditation. “In addition, the ACR reviewer did not agree with nine out of the 30 interpretations.”
“Many of the deficiencies were severe,” according to Weigert. “The ACR believes that this facility’s practice poses a ‘serious risk to human health’ based on specific comments from the clinical image reviewer.”
Mammography centers are reviewed once every three years, according to Rebecca Clark, speaking for the Illinois Emergency Management Agency, which regulates radiology centers in the state, but “in the case of Belleville Imaging, IEMA requested ACR to conduct an additional mammography review,” which is “conducted ‘for cause’ when a problem with clinical image quality is suspected.” It is the first time Belleville Imaging has needed an additional review, Clark added.
Belleville Imaging sent 2,100 patients a letter explaining the review in September and October. Mary Nettleton, of Belleville, got hers on Nov. 1.
Nettleton, who had three examinations during the timeline of ACR’s review, said she was “concerned and worried” about the results of the review, especially because she had to go back to Belleville Imaging for an ultrasound after her second examination.
“How did this get away for three years and nobody catches this?” she said.
The letter said, “This notification does not mean the results given you and your physician were wrong or inaccurate, however, patients will need to have their mammograms... reviewed to determine whether a repeat mammogram at another facility is needed.” The letter advised recipients to contact Belleville Imaging to let it know where to send their old images.
But, in addition to failing the clinical standards for mammography, Belleville Imaging wrote that images from 2015 could be lost due to computer failure.
“You would think that they would back this stuff up,” Nettleton said.
Belleville Imaging had contracted with Esse Healthcare in St. Louis to read the examinations, according to the letter, but it will no longer review mammograms in Illinois.
Esse Healthcare did not respond to a request for comment.
The American College of Radiology stated that its top concerns included problems with breast positioning and compression, noise, and film exposure, contrast and sharpness.
ACR disagreed with the findings of nine examinations, noting that it had spotted eight abnormalities that weren’t recommended for followups as well as one image that led a doctor to request an unnecessary MRI. “The annual MRI is typically for high-risk patients, and this patient is not considered a high-risk patient,” the report noted.
After receiving ACR’s review on Aug. 26, IEMA issued an emergency order immediately suspending Belleville Imaging’s mammography service on the following Tuesday.
IEMA also approved the letter Belleville Imaging sent to patients. All letters were sent by “accountable mail” that required a signature upon delivery, and if delivery wasn’t possible, then Belleville Imaging had to inform affected patients’ doctors and keep a list of those who were contacted.
According to the emergency order, Belleville Imaging may reapply for certification to conduct mammograms when quality standards have been met.
Belleville Imaging manager David Horace said each mammography image has to meet 19 different characteristics for evaluation. Although, if not every one of them is met, it doesn’t mean that the image is totally unreadable. Someone reading the image can still often make a diagnosis.
Esse Health in St. Louis had read around 30,000 images for Belleville Imaging in the past 15 years, Horace said. He remembered only one time in which a radiologist who used to work there had a “delayed diagnosis,” or a diagnosis that could have been identified earlier.
Moreover, Horace said, “you can have the best image in the world, and if the radiologist gets distracted, then yeah, there could be an error,” he said.
He thought that the most important thing right now was informing patients about where they can retrieve their previous images. Belleville Imaging is transferring them to the Breast Health Center at Memorial Hospital. They will be available for pickup after Friday.