Calif. center stops mammography screening

By staff writers

December 20, 2019 -- An imaging facility in Southern California had its accreditation revoked earlier this year and is no longer performing mammography after an audit revealed that 21 of the site's 30 breast screening cases did not meet image quality standards.

The American College of Radiology (ACR) revoked the accreditation held by Radiology Disc of Encino under the Mammography Quality Standards Act (MQSA). The U.S. Food and Drug Administration (FDA) has declared that mammography performed at the center is "a serious risk to human health" and has ordered the facility to notify its patients of problems at the facility.

Radiology Disc's problems started in April 2019 when, during an annual MQSA inspection, the facility was cited under the Enhancing Quality Using the Inspection Program (EQUIP) regulatory framework. In May, the FDA notified the site that it would have to undergo an additional mammography review (AMR) performed by ACR due to the citations.

In the review, the ACR found "serious deficiencies" in Radiology Disc's performance, and the facility was asked to provide additional cases. Radiology Disc failed the expanded AMR, however, with 21 of 30 cases not meeting the ACR's standard for clinical image quality. That prompted the ACR to revoke the center's accreditation and the FDA to issue its "serious risk" notification.

Radiology Disc went on to notify patients and healthcare providers of the FDA's notification requirements. The FDA told the facility that it had successfully met the agency's requirements on December 18. Radiology Disc is currently not performing mammography, according to an FDA adverse event report.

Copyright © 2019

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