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  1. Mammography Quality Standards Act and Program

Mammography Facility Adverse Event and Action Report - May 3, 2016: Giao Van Le MD Inc.

Mammography Facility Adverse Event and Action Report - May 3, 2016: Giao Van Le MD Inc.

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 Subject of an Adverse Action

The State of California

Facility Name and Address:
Giao Van Le, MD Inc.
8130 W McFadden Ave.
Suite #100
Westminster, CA 92683

Facility ID Number:
186528

Adverse Event:
On August 11, 2015, the America College of Radiology (ACR) denied the facility’s request for renewal of accreditation based on deficiencies with the clinical images that were submitted during the accreditation renewal process. On August 28, 2015, the ACR reported to the Food and Drug Administration (FDA) that an unqualified person was performing mammograms at the facility.

On October 5, 2015, the facility’s MQSA certificate expired and the facility could not legally perform mammography.

Action Taken:
On September 2, 2016, The State of California issued a Notice of Violation and Radiation User’s Declaration, requiring the facility to immediately cease performing mammography under State authority. On November 10, 2015, the FDA requested that the ACR perform an Additional Mammography review (AMR) of the mammograms performed by this facility due to the fact that an unqualified person had performed mammography. On December 18, 2015, the ACR notified the facility and the FDA that the clinical images reviewed for the AMR did not meet the ACR’s criteria for clinical image quality.

Corrective Action:
Based on the 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 and was notified of such by the FDA on March 24, 2016.

The State of California issued a license to the facility after all State violations were resolved.

Status of the Facility:
The facility’s accreditation has been reinstated. The facility is currently certified and performing mammography.