MQSA stands for the Mammography Quality Standards Act, a federal law passed in 1992 that requires every mammography facility in the United States to meet minimum quality standards and obtain certification before performing a single mammogram. The law was created to ensure that all women benefit equally from early breast cancer detection, regardless of where they get screened. The FDA has overseen the program since 1993.
Why MQSA Exists
Before MQSA, mammography quality varied widely from facility to facility. Some clinics used poorly maintained equipment, and there were no uniform requirements for the people reading the images. The law established federal standards covering every part of the mammography process: the equipment, the staff, the images, and how results are communicated to patients. It was the first time the federal government set quality standards for a specific medical imaging procedure.
How Facilities Get Certified
No facility can legally perform mammography without an FDA-issued certificate. To get one, the facility must first be accredited by a federally approved accreditation body. The American College of Radiology (ACR) is the primary accreditation organization, though certain states (like Arkansas) have their own FDA-approved programs. Facilities in those states can choose either the state program or the ACR.
The accreditation process evaluates whether a facility meets MQSA’s requirements for equipment performance, image quality, and staff qualifications. Only after passing accreditation can a facility apply for its FDA certificate.
Staff Qualification Requirements
MQSA sets specific education and experience thresholds for three key roles: the radiologist who reads the mammograms, the technologist who performs them, and the medical physicist who tests the equipment.
Medical physicists, for example, need at least a master’s degree in a physical science with 20 semester hours of physics, plus hands-on training surveying mammography facilities. They must also hold board certification or state licensure. To stay qualified, they’re required to survey at least two mammography facilities and six mammography units every 24 months, and complete 15 hours of continuing education in mammography every three years. Similar ongoing requirements apply to radiologists and technologists, ensuring that credentials don’t go stale.
Equipment and Image Quality Standards
MQSA mandates regular quality control testing at multiple intervals. Weekly, facilities must check image quality using a standardized test object called a phantom, which simulates breast tissue. The resulting image must meet minimum scores for density and contrast, and readings can’t drift more than small, defined amounts from the facility’s baseline.
Annual testing is more extensive. A medical physicist evaluates the equipment’s radiation output, beam quality, and dose levels. The single most important safety threshold: the average radiation dose delivered during a standard mammogram view cannot exceed 3.0 milligray per exposure. That limit applies to both traditional film systems and newer digital systems. The physicist also checks that the automatic exposure control is consistent, with variation kept below 5%.
Annual Inspections and Enforcement
Every certified facility is inspected once a year, typically within a 10 to 14 month window from the previous inspection. The FDA can also inspect any facility at any time “for cause” if problems are suspected.
Inspectors assign one of three levels when they find a problem. Level 1 is the most serious, meaning something may seriously compromise the quality of mammography services. The facility must respond within 15 working days. Level 2 means performance is generally acceptable but one or more issues could compromise quality, requiring a response within 30 working days. Level 3 covers minor deviations that don’t need a formal response but will be checked at the next inspection.
As of fiscal year 2024, about 77.7% of inspections found no noncompliance at all.
What MQSA Means for Patients
MQSA directly shapes what happens after your mammogram. Facilities must provide you with a written summary of your results within 30 calendar days of the exam, whether that’s a printed letter, an entry in a patient portal, or a handout at the time of the visit. A more detailed technical report goes to your doctor or healthcare provider.
If results are suspicious or highly suggestive of malignancy, the timeline tightens significantly. The facility must get a written summary to you within seven calendar days of the final interpretation, even if someone already told you the results by phone.
Breast Density Reporting
A major recent update to MQSA requires all facilities to include breast density information in the patient summary. Dense breast tissue can make cancers harder to spot on a mammogram, and the updated rules provide specific language explaining this. The summary now recommends that patients with dense breasts talk to their healthcare provider about their individual risk factors and whether additional screening might be appropriate.
How Long Your Records Are Kept
Facilities must retain your original mammogram images and reports for at least five years. If you don’t return for another mammogram at that facility, the retention period extends to 10 years. State or local laws may require even longer retention. If you switch facilities, you can request that your prior images be transferred so your new provider has comparison films.
How to Check a Facility’s Status
Every MQSA-certified facility is required to display its FDA certificate. You can also search the FDA’s online database to verify that a facility is currently certified and to see the results of its most recent inspection. If a facility isn’t certified, it cannot legally perform mammograms, and any mammograms it performs wouldn’t meet federal quality standards.