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U.S. Department of Health and Human Services

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Mammography Facility Adverse Event and Action Report - July 18, 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 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 Iowa Accreditation Body (SIA AB) & the State of Iowa Certifying Agency (SIA CA)

Facility Name and Address:
Webster City Medical Center
610 Collins Street
Webster City, IA 50595

Facility ID Number:
146001

Adverse Event:
During a random onsite visit the SIA AB noted some quality issues with the facility’s clinical and phantom images. As a result, the SIA AB initiated an Additional Mammography Review (AMR). The SIA AB clinical image reviewers determined the facility posed a serious risk to human health.

Action(s) Taken:
The SIA AB suspended the facility’s accreditation. When the SIA AB notified the SIA CA that the facility failed its AMR (with a serious risk to health) and that it suspended the facility’s accreditation, the SIA CA suspended the facility’s certification. The SIA CA required the facility to perform a Patient – Physician Notification (PPN).

Corrective Action:
Facility replaced its mammography equipment and provided training to its technologists and interpreting physicians. Also, the facility completed all of its PPN requirements and the SIA CA issued the facility a closeout letter on June 23, 2011.

Status of the facility:
Fully accredited and certified and operating, effective June 27, 2011.

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.