Mammography Quality Assurance

Mammography Inspections

A mammography system includes the x-ray machine, quality control and processing equipment, technologist and interpreting physician. Each mammography system that receives a certification, will be inspected within 60 days of receiving its certification. After the initial inspection, each certified mammography system is inspected annually.

Posting Requirements

Certificate of Inspection

After a satisfactory inspection, the agency will issue a Certificate of Inspection. The certificate shall be posted in a conspicuous place on or near where the mammography system is used.

Notice of Failure

Any severity level I violation involving a mammography system constitutes grounds for posting a Notice of Failure of the mammography system. Severity level I violations are the most significant and may have a significant negative impact on public health and safety. Therefore, the Notice of Failure must be posted:

• on the mammography x-ray unit in a conspicuous place if the violation relates to the machine; or
• in a place near the mammography system is operated if the violation is personnel related; and
• in a sufficient number of places to allow patients to observe the notice.

The Notice of Failure shall remain posted until the facility is authorized to remove it by Radiation Control.

Patient Notifications

Registrants who receive a Notice of Failure due to a severity level I violation, are required to notify the patients who had a mammography performed at the facility during the 30 days preceding the date of the inspection. The facility shall:

• inform the patient that the mammography system failed to meet the agency's certification standards;
• recommend that the patient have another mammogram performed at a facility with a certified mammography system;
• list the 3 closest facilities to the original testing facility that have a certified mammography system;
• explain the failure of the mammography system and
• explain the potential consequences to the patient.

Need more information? Contact us.

Mammography Inspections

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Texas Department of State Health Services, Radiation Control Program
1100 West 49th Street - Austin, Texas 78756-3189 - (512) 834-6688 or (512) 834-6770

Last Updated September 27, 2006