Mammography Facility Adverse Event and Action Report - October 30, 2018: Osteopathic Medical Associates of Nevada

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 Nevada

Facility Name and Address:
Osteopathic Medical Associates of Nevada
5410 W Sahara Ave.
Las Vegas, NV 89146

Facility ID Number:
194357

Adverse Event:
On June 14, 2018, The American College of Radiology (ACR) initiated a Limited Additional Mammography Review (LAMR) of mammograms performed by this facility based on serious deficiencies with quality control parameters found during the annual MQSA inspection performed by the State of Nevada on May 15, 2018, as well as during a Headquarters-Initiated MQSA inspection performed by a Food and Drug Administration (FDA) Regional Health Representative on July 28, 2018.

The ACR notified the facility on August 17, 2018, that the results of the LAMR revealed that three (3) out of six (6) clinical cases reviewed failed to meet the ACR’s clinical image evaluation criteria.

Action Taken:
Based on the failed LAMR results as well as ongoing quality concerns the FDA required, under the authority of the MQSA [21 CFR 900.4(a)(1)(ii)], the ACR to revoke the facility’s accreditation, which it did, effective August 17, 2018.

Furthermore, on August 21, 2018, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 LAMR and ongoing quality concerns, 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 October 24, 2018.

Status of Facility:
The facility is currently not performing mammography.