Radiation-Emitting Products

Mammography Facility Adverse Event and Action Report - July 15, 2015 (Updated January 20, 2017): Bio Family Clinic PC

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. If new or revised information comes to FDA’s attention we will post updates as appropriate.

Mammography Facility Subject to An Adverse Action

The State of Arizona

Facility Name and Address:
Bio Family Clinic PC
11468 N Frontage Road, Suite A
Yuma, AZ 85367

Facility ID Number:
240371

Adverse Event:
On December 08, 2014, the Food and Drug Administration, Division of Mammography Quality Standards (DMQS) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to MQSA inspection findings which revealed this facility failed to perform the manufacturer required quality control tests during a five month period. On March 16, 2015, the ACR notified the facility that a number of mammograms reviewed during the AMR were deficient and did not meet the ACR’s criteria for clinical image quality.

Action Taken:
Under State regulations, the State of Arizona ordered the facility to cease performing mammography following the February 26, 2014 MQSA inspection. The State of Arizona also levied a $2,000.00 civil money penalty against the facility.

The ACR requested the facility to submit a corrective action plan by March 27, 2015, to address the clinical image quality deficiencies.

Corrective Action:
On April 14, 2015, the facility submitted an adequate response to FDA that addressed the MQSA inspection findings. On June 03, 2015, the facility received approval from the ACR for the submitted corrective action plan documentation. The facility’s technologist also completed the State required mammography quality control training and the facility has paid the State levied civil money penalty.

In August of 2016, the facility attempted reaccreditation but failed to submit required documentation by required deadlines. The ACR revoked the facility’s accreditation on 12/12/2016. On 12/13/2016, the FDA issued a letter to the facility stating that the facility’s MQSA certificate was no longer in effect and the facility must cease performing mammography until such time as the facility’s accreditation is reinstated and the facility has complied with all FDA requirements.

Status of the Facility:
The facility is currently unaccredited and does not have a valid MQSA certificate. The facility is not performing mammography.
 

Page Last Updated: 12/01/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English