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 Florida

Facility Name and Address:
Radiology Associates
7525 SR 52
Bayonet Point, FL 34667

Facility ID Number:
224581

Adverse Event:
On April 23, 2018, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to a letter submitted by the facility to the American College of Radiology (ACR) stating that from February 4, 2015 until the most recent tube replacement on March 5, 2018, the facility imaged patients using a Molybdenum (Mo) and a Rhodium (Rh)/Silver (Ag) filter combination.

On June 18, 2018, the ACR notified the FDA and the facility that the AMR revealed serious deficiencies with clinical image quality and failed to meet the ACR's clinical image evaluation criteria.

Action Taken:
On June 21, 2018, the ACR revoked the facility's mammography accreditation.

On June 22, 2018 the FDA declared the facility's MQSA certificate to be no longer in effect until such time as the facility's accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 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 as such by the FDA on September 6, 2018.

Status of the Facility:
The facility's accreditation was reinstated and the facility was issued an MQSA certificate. The facility is currently performing mammography.