Radiology providers resume breast imaging after months-long ‘odyssey’ over quality concerns
Two separate radiology providers have resumed performing mammography exams following months-long suspensions, triggered by concerns from the FDA and American College of Radiology.
Those include the Winchester Medical Center in Virginia, which hadn’t conducted such breast imaging tests in nearly six months. Services first halted on Aug. 31 when an annual ACR inspection determined that providers improperly positioned some patients, leading to scans that weren’t quite sharp enough, the Winchester Star reported.
“It has been quite the odyssey,” Mark Merrill, president and CEO of Valley Health, Winchester Medical Center’s corporate parent, told the newspaper.
Merrill noted that equipment was functioning properly when the poor-quality images were collected between June 2017 and August 2019. On average, the hospital’s diagnostic center produces about 550 mammograms each week.
Following the suspension, WMC set up a call center for concerned individuals and eventually sent out 25,000 letters to patients as part of a corrective plan devised by the FDA. Under the guidance, Valley Health is also retraining staffers at all six of its hospitals on proper mammography methods. After completing this work, the health system is also adding additional staff and another unit to help handle higher patient volumes.
Meanwhile, another imaging provider in Raleigh, North Carolina, also recently resumed screening mammography after a similar suspension. Raleigh Radiology Blue Ridge officials shared on their website that they’ve also completed an FDA corrective action plan and received the agency’s blessing to resume such services.
The practice said a clerical error led to one of its mammogram units gaining incorrect accreditation from ACR. That spurred a college review of its mammography images. Laura Thomas, director of breast imaging, noted in December that the ACR’s review only looked at the technical quality of mammography images, and the vast majority were deemed to be acceptable, with no overlooked cancer or disease.
A former patient sued Raleigh Radiology in December, determined to find out whether her own images were included in the set of scans reviewed by the ACR and FDA. At the time, Wake County resident Emily Cram had demanded a refund for her care and class-action status for the lawsuit to include other patients imaged at the practice.
In a statement posted to its website, Raleigh Radiology apologized for the timing of its notification letters, some of which were delayed in delivery during the holidays.
“We understand many feel we have not been transparent or that we have not provided information when it was requested,” the provider wrote. “We were required to follow a strict set of guidelines to ensure we provided each of you a consistent response. Our nature is to be friendly, open, honest and forthcoming and we have also been frustrated by our inability to have open dialogue prior to completing the notification process.”