FDA yanks MQSA certificate from imaging facility in Md.

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The U.S. Food and Drug Administration (FDA) has revoked the certification under the Mammography Quality Standards Act (MQSA) of a mammography facility in Maryland that has a history of problems with image quality.

In a June 30 statement, the FDA said it has revoked the MQSA certification of Capitol Radiology, doing business as Laurel Radiology Services of Laurel, MD. The facility is now considered to be unaccredited and uncertified to conduct mammography and cannot legally provide breast imaging services, the statement said.

The FDA originally made an announcement about problems at the facility in 2021. At the time, the FDA said the site failed to obtain accreditation of its 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 review workstation compliance quality control test for at least 12 consecutive weeks.

The FDA said it sent a letter to the facility in March 2021 instructing the center to send notification letters to all at-risk patients and their referring healthcare providers. The facility has failed to perform the notifications, the new FDA statement said.

As such, Laurel Radiology Services cannot legally provide mammography services for a two-year period from May 2022 to May 2024, and the operators of the facility are barred from owning or operating a facility requiring an MQSA certificate for that two-year period.

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