by Ashley Hu, MD, and Jane Dascalos, MD
The Mammography Quality Standards Act (MQSA) is a law passed by the federal government to regulate the quality and standards for a mammographic facility and its images. The Food and Drug Administration (FDA) is responsible for overseeing this process, by conducting inspections as is required by the law. Currently, all mammographic facilities must be accredited by an FDA-approved accreditation body in order to operate and be compensated by insurance companies. Without this accreditation, the facility is deemed to be operating illegally. The MQSA outlines the requirements needed for operation and accreditation, including personnel training, equipment standards, imaging reporting, specifications, and storage, and quality assurance.
There are established training requirements for personnel involved in the process of obtaining and interpreting a mammogram. The following are required for the different categories of personnel:
Equipment used for mammography cannot be used for general purposes; it must be specialized for mammography. Additional technical specifications for components of the mammographic unit, such as the image receptor and compression paddle, are outlined in detail in the MQSA documents.
The contents of a mammographic report are clearly outlined by the MQSA. Each report must contain:
This final report is sent to the health care provider in a timely manner, but no later than 30 days after the examination date. If the findings are suspicious (BI-RADS 4) or highly suggestive of malignancy (BI-RADS 5), the interpreting physician also has a responsibility to communicate these findings directly to the health care provider as soon as reasonably possible. In addition to the final report, an additional report written in language understandable by the patient must be delivered to the patient within 30 days of the examination.
Mammographic films and reports must be kept for a minimum of 5 years for actively operating facilities, and a minimum of 10 years for facilities that are no longer performing mammograms. The original films and reports must also be sent to a health care institution, physician, or patient if requested by the patient or on behalf of the patient.
Mammographic image requirements
On each mammographic image, the following information must be present:
These are to be placed in a permanent manner on a visible location on the film, without obscuring breast anatomy.
Individuals responsible for the quality of the services and images at a mammographic facility include the appointed Lead Interpreting Physician, interpreting physicians, medical physicist, and appointed Quality Control Technologist.
To ensure that the equipment is working correctly and optimally, certain tasks are required to be performed consistently. These range from daily to annually, and are most specifically outlined in the MQSA for screen-film systems. For non-screen-film systems, the MQSA recommends quality checks based on manufacturer recommendations. The only exception to this is that the average glandular dose to the FDA phantom breast should not exceed 3 milligray per exposure on a single craniocaudal view, regardless of imaging modality.