September 25, 2020: Allison Breast Center Monument Radiology Safety Alert Issued For Mammography Problems Reports FDA

Allison Breast Center Monument Radiology Safety Alert Announced – This Safety Alert is intended for Patients, Health Professionals, Risk Managers, and Radiology.

The U.S. Food and Drug Administration (FDA) has issued a safety alert for patients who had mammograms at the Allison Breast Center at Monument Radiology, located in Richmond, VA, on or after June 17, 2018, due to possible problems with the quality of their mammograms.

Allison Breast Center Monument Radiology Safety Alert Background Information

According to the FDA, the facility did not meet the standards for mammography quality under the Mammography Quality Standards Act (MQSA) of 1992.  Therefore, the facility may not legally perform mammography at this time, as it does not have an active MQSA certificate, reported the FDA.

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.

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

FDA Allison Breast Center Monument Radiology Safety Alert Recommendations

The FDA has made the following safety recommendations to patients and members of the health care community:

  • 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.
    • Patients who would like to request a copy of their records should submit a written request by mail with the patients full name, date of birth, patients signature, and the address of the location where the patients medical records should be sent.

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