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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 - August 3, 2012

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 Nebraska

Facility Name and Address:
Community Hospital
1301 East H St.
McCook, NE 69001

Facility ID Number:
197962

Adverse Event:
On 12/27/2011, this facility was notified by its accreditation body, the American College of Radiology (ACR), that it must participate in an Additional Mammography Review (AMR) due to serious problems found during clinical image review for accreditation renewal. The AMR revealed serious problems involving the quality of mammography. The facility voluntarily ceased performing mammography.

Action Taken:
The ACR denied the facility’s application for renewal. On 3/22/2012, the FDA notified the facility that based on the significant risk to individual or public health found during the AMR, it was required to perform a Patient and Referring Healthcare Provider Notification (PPN), which involved notifying all at-risk patients about possible problems with their mammograms.

Corrective Action:
The facility successfully completed the PPN process. On 7/24/2012, the ACR notified the facility that it passed its post-reinstatement AMR and the ACR granted the facility full accreditation.

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.