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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Mammography Facility Adverse Event and Action Report - March 21, 2011

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 the past, we have put a report up on the web once a year and then increased the frequency to twice a year. In keeping with our recent announcement that in order to provide this information in the most timely manner, we are now posting the following information in “real time,” as this action taken against a mammography facility has concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of California

Facility Name and Address:
Huntington Radiology
2679 Zoe Avenue
Huntington Park, California 90255

Facility ID Number:
238361

Adverse Event:
FDA received a report from the Los Angeles County Department of Public Health - Radiation Management regarding an investigation it conducted at the facility on March 30, 2010. The investigation found that mammograms were being performed at the facility by an employee who had no documented training as a radiologic technologist. The County conducted the investigation after receiving a complaint about the facility.

Action Taken:
On July 7, 2010, the FDA required the facility to undergo an additional mammography review (AMR).

On August 18, 2010, the ACR notified FDA that the facility failed the AMR at a level considered a serious risk to human health.

On August 31, 2010, the American College of Radiology (ACR) revoked the facility’s accreditation and FDA subsequently declared the facility’s MQSA certificate no longer in effect due to the accreditation revocation.

On September 3, 2010, the State of California issued an order to the facility to immediately cease operation of its mammography unit and to immediately cease and desist performance of mammography.

On September 9, 2010, FDA required the facility to notify all patients and their referring healthcare providers of the facility’s quality issues. This notification included those patients who had mammograms performed at the facility during the time period September 9, 2008 through September 9, 2010.

Corrective Action:
Because the facility was unable to demonstrate to FDA’s satisfaction that all affected patients and their health care providers had been successfully notified, FDA posted a safety notification on its website on March 10, 2011, notifying women who had mammograms performed at the facility from September 9, 2008 through September 9, 2010 of the mammography quality issues at Huntington Radiology and the steps they should take.

Status of the Facility:
Not performing mammography.

HOW TO FIND AN FDA-CERTIFIED FACILITY

Cancer Information Service

To operate legally, a mammography facility must have and prominently display an FDA MQSA facility certificate or a similar certificate from an FDA-approved State certifying agency. This certificate shows that the mammography facility is certified as meeting baseline quality standards for equipment, personnel, and practices under the MQSA. Consumers and health professionals can locate MQSA-certified facilities in their geographic area by calling the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). Information specialists at this number are trained to answer questions about mammography and breast cancer. Written documentation on mammography and breast cancer is also available on request.

Internet

The FDA Mammography Web Site provides a listing of all MQSA-certified facilities by selected State or U.S. territory and zip code.

National Technical Information Service

A list of all MQSA-certified mammography facilities, updated quarterly, is available on CD-ROM (for a fee) through the:

National Technical Information Service (NTIS)
5301 Shawnee Road
Alexandria, VA 22312
http://www.ntis.gov/disclaimer icon

Tel. 1-800-553-6847
NTIS Order No, SUB-5386