Breast Mammogram - Mobile X-Ray
The Mammography Quality Standards Act (MQSA)
The primary objective of the Mammography Quality Standards Act (MQSA) of 1992 is to ensure that mammography is safe
and reliable and that breast mammograms detect breast cancer in its most treatable stages. The Food and Drug Administration has the responsibility for implementing and
enforcing MQSA, which requires that all mammography facilities and mobile xray services in the United States meet certain stringent quality standards, be accredited by an FDA
-approved accreditation body, and be inspected annually.
Physicians who interpret mammograms must now be board
certified or have three months of training in mammography, technologists must keep their skills current by doing an
average of 200 mammograms every two years, and medical physicists, who survey mammography equipment and
facilities, must meet initial and continuing education and experience requirements.
Of significant importance to women is the MQSA regulation that requires mammography facilities and mobile x-ray
facilities to give patients an easy-to-read report on the results of their mammogram. Prior to MQSA, mammography
facilities were not required to communicate results directly to patients and, instead, sent results only to the referring
physician. Referring physicians will continue to receive the results. Self-referred patients with no designated health-care
provider will receive both the simplified report and the one doctors normally receive.
MQSA also clarifies the responsibility of facilities that provide breast mammograms to retain and transfer mammograms
to a patient's physician or to the patient directly, regardless of whether the transfer is permanent or temporary. This is
important because it aids diagnosis by allowing doctors to compare old mammograms with new ones.
To be MQSA-certified, a mammography facility must be accredited by a federally approved private, nonprofit or state
accreditation body. FDA has approved the American College of Radiology (ACR) and some States as accreditation bodies.
To be accredited, the facility must apply to an FDA-approved accreditation body, undergo periodic review of its clinical
images, have an annual survey by a medical physicist, and meet federally developed quality standards for personnel
qualifications, equipment quality assurance programs, and record keeping and reporting. Our mobile X-ray facility must
also undergo an annual inspection conducted by federally trained and certified federal or state personnel. The certificate
is displayed at our facility. FDA encourages women getting breast mammograms to look for this certificate
Ensuring High-Quality Mammography and Breast Mammograms
FDA has focused on the quality of breast mammograms since 1974, when it was revealed that mammography
techniques used in some medical facilities had resulted in unnecessarily high doses of radiation. Since then the industry
has worked continuously to improve the equipment and as a result radiation doses began to decrease. The American
College of Radiology agreed to try to help with the mammography quality assurance challenge and in 1987 established
its mammography accrediting program. Since then FDA regulated the equipment and ACR policed the facilities.
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