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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 - December 9, 2010

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 Iowa

Facility Name and Address :
Community Health Care, Inc.
500 West River Dr .
Davenport , IA 52801

Facility ID Number :
#238053

Adverse Event :
The facility's management reported to the State of Iowa that it terminated one of its mammography quality control (QC) technologists because it found that the technologist falsified QC records.

Action Taken :
A review of the facility's mammography program confirmed the falsification of QC records. The State of Iowa's Permit Program initiated an investigation to determine whether it would take any action against the individual’s "permit to practice" x-ray.

Corrective Action :
On November 29, 2010, the State of Iowa's Permit Program sent an order to the technologist suspending the technologist's State of Iowa X-ray Permit for 180 days.

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.