FDA revokes Va. facility's mammography accreditation

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The U.S. Food and Drug Administration (FDA) has revoked its Mammography Quality Standards Act (MQSA) certificate for Allison Breast Center at Monument Radiology in Richmond, VA. The agency said any patient who was seen on or after June 17, 2018, may have a problem with the quality of their mammograms.

The state of Virginia issued an order of summary suspension and notice of formal administrative hearing and statement of allegations for Allison Breast Center's primary interpreting physician. The order suspended the physician's medical license and, as a result, the FDA requested documentation to determine if the physician's responsibilities had been assigned to another MQSA physician. They had not. Consequently, the FDA required the facility to participate in an additional mammography review to determine if the overall quality of mammography performed at the facility was compromised.

Allison Breast Center did not respond to that request or to the request by the American College of Radiology (ACR) to engage in the additional mammography review. Therefore, the ACR revoked the facility's accreditation on August 11.

As of August 12, the FDA revoked the Allison Breast Center's MQSA certificate, which means the facility may not legally perform mammography at this time. On August 27, the FDA directed Allison to notify all patients who received mammograms at its facility on or after June 17, 2018, along with their referring healthcare providers, about the problems with the mammography quality at the facility. Allison Breast Center has not done so, according to the FDA. In a safety communication, the FDA advises patients to have their mammograms reviewed elsewhere.

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