To alert healthcare providers and patients about the questionable quality of mammograms performed at a Maryland healthcare facility, FDA issued the following statement by David Lee, MD, director, Division of Mammography Quality Standards, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health:

The FDA is alerting patients and health care providers that there may be problems with the quality of mammograms performed on or after June 26, 2018, at Capitol Radiology LLC, also known as Laurel Radiology Services, in Laurel, Maryland. This facility no longer has a valid Mammography Quality Standards Act certificate and is not legally able to perform mammography at this time.

The annual required inspection of the facility revealed that the business failed to meet several requirements of the Mammography Quality Standards Act. As a result, the facility’s accreditation body conducted a review of mammograms performed at Capitol Radiology LLC and found that many images did not meet the required clinical image evaluation criteria.

The FDA’s top priority is the safety and health of patients. We will continue to monitor this issue and keep the public informed as new information becomes available. At this time, the FDA recommends that patients contact Capitol Radiology to gain access to their medical records and, in some cases, they may require follow-up imaging with another facility.

For more information, read the FDA’s safety communication.