UPDATE ON MAMMOGRAPHY SERVICES AT RALEIGH RADIOLOGY BLUE RIDGE
A Message to Our Patients and Community from Raleigh Radiology
At Raleigh Radiology, we are committed to serving our community by offering state-of-the-art imaging services and straight from the heart care. We understand there has been some confusion and concern about mammography services at our Blue Ridge facility. We are extremely sorry for any distress or inconvenience this matter has caused and we would like to provide additional information about what happened, what we’ve done about it, and what it means going forward.
Raleigh Radiology Blue Ridge had one mammogram unit that was not accredited correctly with the American College of Radiology (ACR) due to a clerical mistake. Because of this error, the ACR recently conducted a review of mammography images at our Blue Ridge facility. The review was limited to a very small number of our mammography cases.
The ACR uses multiple criteria when assessing mammographic quality. These include things like compression, exposure level, contrast, sharpness, noise, artifacts, exam identification and positioning. We did not receive any criticism or comments from the ACR on the first seven factors. Importantly, the majority of cases reviewed were acceptable to the ACR, and neither the ACR nor the U.S. Food and Drug Administration (FDA) have indicated that any visible cancer or disease on any image was overlooked. However, the ACR reviewers noted issues with the technical quality of some of the images.
Unfortunately, one image set in the sample had significant problems with the breast positioning and the reason for the difficulty performing that mammogram was not documented. As a result, the ACR recommended we cease mammography services completely at our Blue Ridge facility. The Blue Ridge facility remained open for all other types of imaging services, and our other facilities continued to perform mammography. However, the FDA withdrew Raleigh Radiology’s certification at the Blue Ridge facility, pending patient and doctor notification, as well as completion of a Corrective Action Plan by the ACR.
What We Have Done
- Notified Affected Patients and Their Referring Physicians
- We notified patients who received mammograms at the Blue Ridge facility between November 7, 2017 and November 6, 2019, as well as their referring physicians. The FDA has strict requirements about how the letter was worded and when it had to be sent.
- We understand many feel we have not been transparent or that we have not provided information when it was requested. 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.
- We also regret the unfortunate timing of the notification letters, which was also mandated by the FDA. We understand that several letters were delayed by the U.S. Postal Service due to the holidays.
- Established a Hotline for Patients – (919) 532-2387
- We established a dedicated hotline for patients to call to alleviate their concerns. This hotline is still available and we encourage patients who have questions about this matter to call our hotline at (919) 532-2387.
- Completed A Corrective Action Plan
- The corrective action plan has been completed, accepted by the ACR, and we are confident that the plan is being carried out.
The FDA has determined that our Blue Ridge facility meets the requirements for certification under the Mammography Quality Standards Act (MQSA). MQSA certification means that a mammography facility is capable of providing quality mammography. Raleigh Radiology has and will continue to work closely with both the FDA and American College of Radiology (ACR). The ACR has accepted our Blue Ridge facility’s application for accreditation and we are confident that the testing phase of accreditation will be successfully completed soon.
For patients who had a mammogram 12 months ago or more at our Blue Ridge office, those patients can schedule their annual mammogram at any of Raleigh Radiology’s facilities and request to speak with a radiologist to discuss their annual mammogram. For patients who had a mammogram at the Blue Ridge location less than 12 months ago, those patients can request a review of that mammogram to determine if a no cost, repeat mammogram is needed. Patients who need to schedule their annual mammogram should call (919) 781-1437. Patients who want to request a review or have questions about this matter are encouraged to call our hotline at (919) 532-2387.
Our physicians and imaging technologists have and will continue to work hard to ensure that our mammography patients are provided excellent radiology services along with compassionate patient care. We thank you for allowing us to serve you and meet your imaging needs.