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The Mammography Quality Standards Act (MQSA) was established by the United States Congress as law on October 27, 1992. MQSA’s overall goal is to “ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages.” MQSA ensures quality mammography through routine inspections by the U.S. Food and Drug Administration (FDA). Upon successful completion of annual inspections, a facility can be certified by the FDA to perform mammograms.
Each facility that performs mammography in the United States (with the exception of Department of Veterans Affairs) is required to:
Be accredited by an FDA-approved accreditation body (either the American College of Radiology [ACR] or the states of Arkansas and Texas).
Meet quality standards for personnel and equipment.
Perform examinations under the maximum allowable radiation dose.
Perform quality assurance, medical audit and outcome analysis, medical record keeping, and abide by reporting requirements.
Facilities maintain their MSQA certification status by:
Having an annual survey performed by a licensed medical physicist.
Undergoing annual inspections conducted by an MQSA inspector.
Correcting deficiencies found during audits.
Prominently displaying MQSA certificate in the facility.
Staying current with inspection fees.
Under federal law, all mammography facilities in the United States are required to comply with the MQSA final regulations. Only facilities with MQSA certification are eligible to receive Medicare/Medicaid payments for screening and diagnostic mammography.
Annual inspections of facilities include the following evaluations:
Personnel qualification records of physicians, technologists, and physicists
Minimal equipment requirements and evaluation of equipment performance
Quality assurance (QA) and quality control (QC) records and tests
Medical records (mammography reports and images) and lay summaries
Medical audit and outcome analysis
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