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Mammography Facility Adverse Event and Action Report - December 19, 2019: Radiology Disc of Encino

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order to provide this information in the timeliest manner, we now post the following information in “real time,” as actions taken against mammography facilities are concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of California

Facility Name and Address:

Radiology Disc of Encino
16661 Ventura Blvd., 100
Encino, CA 91436

Facility ID Number:

190223

Adverse Event:

On April 12, 2019, the annual MQSA inspection revealed Repeat Level 2 Enhancing Quality Using the Inspection Program (EQUIP) citations.  On May 9, 2019, the FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR) performed by its accreditation body, the American College of Radiology (ACR), for failure to demonstrate that the facility met the requirements of the EQUIP initiative.  On June 14, 2019, the ACR notified the facility that the AMR revealed serious deficiencies and the facility was required to provide additional clinical cases for an expanded AMR. 

On August 15, 2019, the ACR notified the FDA that the facility had failed the expanded AMR with twenty-one (21) out of thirty (30) cases not meeting the ACR’s criteria for clinical image quality.

Action Taken:

Based on the failed AMR results, on August 27, 2019, the ACR revoked the facility’s accreditation.

After evaluating the reasons for the accreditation revocation, on August 28, 2019, the Food and Drug Administration (FDA) declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.

Corrective Action:

Based on the serious image quality deficiencies noted during the AMR, the FDA declared the mammography performed at this facility to be a serious risk to human health and therefore required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients and their providers of the mammography quality problems at the facility.

The facility successfully completed the PPN and was notified of such by the FDA on December 18, 2019.

Status of the Facility:

The facility is currently not performing mammography.