FDA in Brief
FDA In Brief: FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology LLC
- For Immediate Release:
The following quote is attributed to David Lee, M.D., 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.”
- Today, the U.S. Food and Drug Administration issued a safety communication to inform patients and health care providers about possible problems with mammograms performed at Capitol Radiology LLC (doing business as Laurel Radiology Services) in Laurel, Maryland on or after June 26, 2018.
- The annual MQSA inspection of the facility revealed that the facility failed to obtain accreditation from ACR for its full field digital mammography unit prior to use on patients. Additionally, the facility failed to perform a required weekly quality control test for at least 12 consecutive weeks between June 16, 2020 through September 12, 2020. As a result, the FDA notified the facility that it was required to undergo an additional mammography review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the MQSA, and whether there was a need to notify affected patients.
- The AMR results indicated that many images did not meet the ACR’s clinical image evaluation criteria, and that some of the deficiencies were severe. On March 24, 2021, the ACR revoked the facility’s accreditation and on March 25, 2021, the FDA placed the facility’s MQSA certificate in a “no longer in effect” status.
- Under the MQSA, the FDA requires all mammography facilities to meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet the standards for mammography quality under the MQSA and may not legally perform mammography at this time, as it does not have a valid MQSA certificate.
- Patients of Capitol Radiology LLC who have had a more recent mammogram at a different MQSA-certified facility on or after June 26, 2018 should follow recommendations from that facility. Those who have not had a mammogram at a different facility on or after this date should consider asking for their mammogram and copies of their medical reports from Capitol Radiology LLC and have their mammogram reviewed at an MQSA-certified facility to decide if a repeat mammogram or more medical follow-up is needed. Patients or their representatives have the right to ask for their mammograms and medical reports.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Audra Harrison