Mammography Facility Adverse Event and Action Report - November 25, 2011
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 most timely manner, we now post 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:
2679 Zoe Avenue
Huntington Park, California 90255
Facility ID Number:
On 7/1/2011, this facility was notified by the American College of Radiology (ACR) that it had failed an extensive image review for accreditation reinstatement. This review was required since the facility had failed an additional mammography review in 2010. On 7/19/2011, ACR notified the facility that it was denied accreditation.
On 7/29/2011, this facility was notified that it must notify patients and their referring health care providers regarding the serious risk to human health found during the image review for reinstatement.
On 11/18/2011, the facility was notified that it had successfully completed the notification.
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.
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 is available on a computer diskette and sold as either a single issue (the most recent diskette) or a subscription (the diskette is updated quarterly) from:
National Technical Information Service (NTIS)
5301 Shawnee Road
Alexandria, VA 22312
To order a single disk, call 1-800-553-6847. The NTIS order number is SUB-5386/Code D01.