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

The State of Louisiana

Facility Name and Address

SBPH-Saint Bernard Parish Hospital/Ochsner
8000 W Judge Perez Dr.
Chalmette, LA 70043

Facility ID Number

238866

Adverse Event

On February 5, 2020, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility, to be conducted by the facility's accreditation body, the American College of Radiology (ACR). The AMR was initiated due to the facility's failure to demonstrate that it met the requirements of the Enhancing Quality Using the Inspection Program (EQUIP) initiative, as well as failure to perform phantom image quality control testing for five consecutive weeks during the annual MQSA inspection performed on January 15, 2020, by the State of Louisiana.

On April 24, 2020, the ACR notified the FDA that the facility had failed the AMR with twenty-nine (29) out of thirty (30) cases not meeting the ACR's criteria for clinical image quality.

Action Taken

Based on the failed AMR results, on May 6, 2020, the ACR revoked the facility's mammography accreditation.

After evaluating the reasons for the accreditation revocation, on May 7, 2020, the FDA declared the facility's MQSA certificate to be no longer in effect until such time as the facility's accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 August 11, 2020.

Status of the Facility

The facility has not applied for re-instatement of its mammography accreditation and is currently not authorized to perform mammography.