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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 – June 15, 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 New Jersey

Facility Name and Address:
St. Joseph’s Regional Medical Center
703 Main Street
Paterson, New Jersey 07503

Facility ID Number:
#139279

Adverse Event:
On March 18, 2011, during an MQSA inspection, the inspector was alerted to poor quality mammograms performed by the facility. The mammography unit recently had a refurbished x-ray tube installed, which was cleared by the medical physicist for clinical use. However, the state determined that the unit was not performing consistently, that patient films were very dark and patient images had to be repeated.

Action(s) Taken:
Due to the inconsistent performance of the unit, the inspector, under state authority, embargoed the mammography unit and informed the facility that the unit could not be used until all conditions of the embargo were satisfied.

Corrective Action:
The facility disposed of the mammography unit and replaced it with a new digital one.

Status of the facility:
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 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
http://www.ntis.gov/

To order a single disk, call 1-800-553-6847. The NTIS order number is SUB-5386/Code D01.