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Mammography Facility Adverse Event and Action Report - November 21, 2019: Methodist Hospital of Southern California

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated that 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

Facility Name and Address:

Methodist Hospital of Southern California
300 W Huntington Dr
Arcadia, CA 91007

Facility ID Number:

196451

Adverse Event:

On April 17, 2019, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to a personnel matter in which mammograms were interpreted by an interpreting physician who was subject to an FDA certificate revocation action that was in effect from March 4, 2016 to March 4, 2018. The interpretation of mammograms by this individual was noted during the MQSA inspection performed on January 29, 2019. The facility’s accreditation body, the American College of Radiology (ACR), conducted the AMR at the request of the FDA.

On May 30, 2019, the ACR notified the FDA and the facility that the AMR revealed serious deficiencies in clinical image quality and that the images reviewed did not meet the ACR’s clinical image evaluation criteria.

Action Taken

On June 11, 2019, the ACR revoked the facility’s accreditation.

Furthermore, on June 12, 2019, the FDA declared the facility’s MQSA certificate to no longer be in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all requirements of the FDA.

Corrective Action:

Based on the serious image quality deficiencies noted during the AMR, the FDA 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 action and was notified of such by the FDA on October 9, 2019.

Status of the Facility:

The facility is currently not performing mammography.