What FDA certification means for a mammography facility
The Mammography Quality Standards Act in plain English: accreditation, annual inspections, staff and equipment standards, and how to check a facility's certificate.
Every place in the United States that performs mammograms, from a large hospital breast center to a mobile van in a parking lot, must hold a certificate from the Food and Drug Administration (FDA). The requirement comes from the Mammography Quality Standards Act (MQSA), passed by Congress in 1992. Every facility on this site appears in FDA's list of certified facilities. Here is what that certificate means and what it does not.
A certificate is required to operate
Under FDA's MQSA regulations, a certificate issued by FDA has been required for the lawful operation of mammography facilities since October 1, 1994 (21 CFR 900.11). To get one, a facility must meet federal quality standards and be accredited by an accreditation body approved by FDA. New facilities can get a provisional certificate that lets them start performing mammograms while they complete the accreditation process. A facility without a valid certificate may not perform mammography; there are limited exceptions, such as facilities of the Department of Veterans Affairs, which operate under their own program.
Accreditation
Accreditation bodies, which include the American College of Radiology and several state agencies, review a sample of each facility's clinical images, equipment test results, and staff qualifications before accrediting it, and again when it renews. A facility must be accredited for each mammography unit it uses. If images fail review, the facility has to fix the problem before it is accredited.
Annual inspections
The law provides for annual inspections of certified facilities, which are usually carried out by trained state inspectors on FDA's behalf (42 U.S.C. 263b(g)). Inspectors check equipment performance and radiation dose, quality-control records, the qualifications and continuing education of the staff, how results are reported to patients and doctors, and the facility's medical outcomes audit, which tracks how its findings compare with later diagnoses. Serious problems can lead to corrective action, additional mammography review, or suspension or revocation of the certificate.
Who must be qualified
MQSA sets minimum qualifications, initial training and continuing education for three groups:
- Interpreting physicians, who read the images, must be licensed, have specific training in mammography and read a minimum number of mammograms to stay qualified.
- Radiologic technologists, who position you and take the images, must be licensed or certified and have mammography-specific training.
- Medical physicists must survey each mammography unit at least once a year and when equipment changes.
What the certificate tells you, and what it doesn't
A current certificate tells you that the facility met federal standards for equipment, personnel and procedures at its last review and inspection, and is subject to ongoing oversight. It does not tell you:
- whether the facility offers 3D mammography (digital breast tomosynthesis), breast ultrasound, breast MRI or biopsy;
- how long you will wait for an appointment or for your results;
- whether it is in network with your insurance;
- how its outcomes compare with other facilities. Where this site can match a facility to a Medicare-certified hospital, its profile shows that hospital's screening recall rate from Medicare data, which is one piece of information but not a full picture of quality.
The medical outcomes audit
Each certified facility must run a medical outcomes audit: it follows up on mammograms it assessed as needing biopsy, tracks which turned out to be cancer, and reviews the results with its interpreting physicians at least once a year. The audit lets each physician compare their own recall and cancer-detection patterns over time. The results are reviewed in inspections but are not published, which is one reason public, facility-by-facility quality figures for mammography are scarce. Medicare's hospital recall rate, shown on some profiles here, is one of the few published measures.
Equipment and radiation dose
MQSA limits the radiation dose for a standard mammogram view and requires regular quality-control tests on every unit, from daily or weekly checks by the technologist to the annual survey by a medical physicist. Equipment that fails a test must be fixed before it is used again for patients. A modern screening mammogram uses a low dose of radiation; the National Cancer Institute's mammograms fact sheet discusses the benefits and possible harms of screening.
How to check a certificate
FDA publishes its certified-facility list and updates it weekly, and you can search it by name, ZIP code or state on FDA's certified mammography facility search. Certified facilities must also display their MQSA certificate where patients can see it. If you have a concern about the quality of a mammogram, MQSA requires facilities to have a consumer complaint process; you can raise it with the facility first and, if it isn't resolved, with its accreditation body.
Mobile mammography
Mobile units are certified under the same rules as fixed facilities. They are a common way for workplaces, community health programs and rural areas to offer screening. A mobile unit usually performs screening mammograms only; if you need follow-up imaging, it will refer you to a fixed facility. Ask where your images will be read and how you will get your results. This site labels facilities whose name or address indicates a mobile unit.
Using this directory
Every facility here was in FDA's certified list on the date shown on its profile. We list them by city with their address and phone number. Featured placement is a flat advertising fee, always labelled, and never changes the order of the list or anyone's certification status. This information is not medical advice; talk with your doctor or other healthcare provider about whether and when to be screened, and confirm a facility's certificate with FDA before your appointment.
General information only, current as of the date above. The information on Mammography Index is not medical advice and does not replace a doctor, nurse, discharge planner or other qualified professional. Do not use it to make decisions about diagnosis or treatment. If you have a medical emergency, call 911. Rules and programs change; check the official sources linked in this guide.