Date Issued: June 30, 2022
The U.S. Food and Drug Administration (FDA) is updating the May 2021 Safety Communication to alert the public that Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland is currently unaccredited and uncertified to perform mammography and cannot legally provide mammography services. The facility's Mammography Quality Standards Act (MQSA) certificate is revoked and the facility cannot legally provide mammography services during the two-year period from May 6, 2022 to May 6, 2024. The owners or operators of the facility at the time of the violations cannot own or operate a facility requiring an MQSA certificate for the two-year period from May 6, 2022 to May 6, 2024. At this time, the FDA recommends that patients contact Capitol Radiology to obtain their medical records. For more information, please see: Mammography Facility Adverse Event and Action: Capitol Radiology.
Recommendations for Patients
- If you have had a more recent mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after June 26, 2018, follow the recommendations from that facility.
- If you have not had a mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after June 26, 2018, follow these guidelines:
- Consider asking for your mammogram and copies of your medical reports from Capitol Radiology, LLC, doing business as Laurel Radiology Services, and have your mammogram reviewed at a MQSA-certified facility to decide if a repeat mammogram or more medical follow-up is needed. As a patient, you or your representatives have the right to ask for your mammograms and copies of your medical reports.
- A database of Mammography Quality Standards Act (MQSA)-certified facilities can be found online, or you can call the National Cancer Institute's information telephone number at 1-800-422-6237 to find a MQSA-certified facility in your area.
A mammogram is a safe, low-dose, X-ray picture of the breast. It is currently the most effective primary screening method for detecting breast cancer in its earliest, most treatable stages.
Summary of Problem or Scope
The FDA became aware of problems associated with the quality of mammograms performed at:
Capitol Radiology, LLC
dba Laurel Radiology Services
7350 Van Dusen Rd.
Laurel, MD 20707
The facility's annual MQSA inspection revealed that the facility failed to obtain accreditation of a Full Field Digital Mammography (FFDM) unit from the facility's accreditation body, the American College of Radiology (ACR), prior to using the unit to image patients. Additionally, the facility failed to perform the required weekly quality control tests of an imaging unit for at least twelve (12) consecutive weeks between June 16, 2020 and 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 ACR conducted the AMR of mammograms performed by Capitol Radiology, LLC dba Laurel Radiology Services ("Capitol Radiology" or "the facility"), and the review identified mammograms that did not meet the ACR's clinical image evaluation criteria and noted 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 determined Capitol Radiology's MQSA certificate shall no longer be in effect (hereafter, "No Longer In Effect Determination").
On March 25, 2021, the FDA sent Capitol Radiology a letter directing the facility to send notification letters to all at-risk patients and their referring health care providers ("PPN letters" or "PPN order"). At-risk patients include those who had mammograms at the facility from June 26, 2018, until and including the date the facility ceased performing mammography. To date, the facility has not performed the ordered notifications.
Under the MQSA, the FDA requires that all mammography facilities 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. This facility may not legally perform mammography at this time, as it does not have an active MQSA certificate.
The FDA 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, LLC, doing business as Laurel Radiology Services, to gain access to their medical records and follow the Recommendations for Patients above.
If you have questions about this communication, please contact the Mammography Quality Standards Act Hotline by phone: 1-800-838-7715, email: [email protected] or fax: 1-443-285-0689.