Date Issued: September 25, 2020

The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Allison Breast Center at Monument Radiology, located in Richmond, Virginia, on or after June 17, 2018, about possible problems with the quality of their mammograms.

Recommendations for Patients

• If you have had a more recent mammogram at a different Mammography Quality Standards Act-certified facility on or after June 17, 2018, follow the recommendations from that facility.
• If you have not had a mammogram at a different Mammography Quality Standards Act-certified facility on or after June 17, 2018, follow these guidelines:
  • Consider asking for your mammogram and copies of your medical reports from Allison Breast Center at Monument Radiology, and have your mammogram reviewed at another Mammography Quality Standards Act-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.
  • According to the website of Allison Breast Center at Monument Radiology, patients who would like to request a copy of their records should submit a written request by mail with the patient’s full name, date of birth, patient’s signature, and the address of the location where the patient’s medical records should be sent. The facility’s instructions ask patients to mail their requests to:
    
    Allison Breast Center at Monument Radiology
    Commonwealth Building
    7301 Forest Ave
    Suite 110
    Richmond, VA 23226 

Summary of Problem or Scope

A mammogram is a safe, low-dose, X-ray picture of the breast. It is currently the most effective primary method of detecting breast cancer in its earliest, most treatable stages.  The FDA became aware of problems associated with the quality of mammograms performed at:

Allison Breast Center at Monument Radiology
7301 Forest Avenue
Suite 110
Richmond, VA 23226

The State of Virginia issued an Order of Summary Suspension and Notice of Formal Administrative Hearing and Statement of Allegations (“VA Order”) for the lead interpreting physician of Allison Breast Center at Monument Radiology. The VA Order suspended the medical license of the lead interpreting physician, who was also the only interpreting physician at the facility, and as a result, the FDA requested documentation demonstrating that the responsibilities of the lead interpreting physician had been assigned to another MQSA-qualified interpreting physician. Based on the information contained in the Order of Summary Suspension and Notice of Formal Administrative Hearing and Statement of Allegation, the FDA required the facility to participate in 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 Mammography Quality Standards Act.

The American College of Radiology (ACR), at the request of the FDA, contacted the facility to request the clinical images and documentation needed to conduct the AMR of mammograms performed at Allison Breast Center at Monument Radiology.  The facility did not comply with the ACR’s request, and as a result, on August 11, 2020, the ACR revoked the facility’s accreditation. On August 12, 2020, the FDA placed the facility's Mammography Quality Standards Act certificate in a "no longer in effect" status.

Under the Mammography Quality Standards Act of 1992, 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 Act. This facility may not legally perform mammography at this time, as it does not have an active MQSA certificate.

On August 27, 2020, the FDA directed the facility to notify all patients who received mammograms at Allison Breast Center at Monument Radiology on or after June 17, 2018, along with their referring health care providers, about the problems with the mammography quality at the facility. To date, the facility has not performed the ordered notifications.

FDA Activities

The FDA will continue to monitor this issue and keep the public informed as new information becomes available.

Contact Information

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.