Frequently Asked Questions About MQSA
The FDA issued a Final Rule to Amend the MQSA Regulations (“2023 MQSA Final Rule”) on March 10, 2023. Facilities subject to the MQSA and its implementing regulations must comply with all the requirements, including the breast density notification, as of September 10, 2024. The information on this web page has been updated further to confirm the amended MQSA regulations, which are now in effect.
What is a mammogram?
A mammogram is a safe, low-dose x-ray picture of the breast. It is currently the most effective primary screening method for detecting breast cancer in its earliest, most treatable stages.
Why should I have a mammogram?
A mammogram can find breast cancer that is too small to be seen or felt. If breast cancer is found early on a mammogram, it can be treated early when it is easier to cure. Early detection may allow a patient to choose breast-conserving surgery and, in some cases, avoid the need for chemotherapy.
How is a mammogram done?
During a mammogram, you stand in front of a special x-ray machine. A radiologic technologist lifts each breast and places it on a platform that detects x-rays. A clear plastic plate then gently presses the breast against the platform. Some pressure is applied for a few seconds to ensure the x-rays capture as much of the breast as possible. This pressure is not harmful and, while it might be uncomfortable, most patients find the discomfort brief and manageable.
Should patients be concerned about radiation dose during mammography?
No. The risk of harm from radiation is very small when compared to the benefits of early breast cancer detection.
What is a screening mammogram?
A screening mammogram is a quick and easy method to detect breast cancer early, when treatment is more effective and survival rates are higher. It involves taking an x-ray of the breast to check for any changes in women who have no symptoms of breast cancer. Typically, two x-ray images are taken of each breast, and a qualified physician trained to interpret mammograms reviews them later.
What is a diagnostic mammography exam?
A healthcare provider uses a diagnostic mammogram to help learn the cause of a person's breast problems such as a breast mass, skin changes, or nipple discharge. Diagnostic mammography takes a little longer than screening mammography because more x-rays are taken. A qualified physician may review the mammograms while you wait.
How will a patient get the results of their mammogram?
A mammography facility must provide each patient with a written summary of the exam results. The summary can be handed to the patient at the time of the exam, provided electronically (e.g., patient portal), or mailed to the patient within 30 calendar days after the exam. The summary must be written in lay terms or words a patient can easily understand. (21 CFR 900.12(c)(2)). A more detailed version of the results will be sent to the patient’s doctor or healthcare provider.
How will patients who do not have a doctor or other healthcare provider get their results?
A mammography facility will provide a patient with the patient's written summary of the results and a copy of the technical report within 30 days of the exam. If necessary, the facility personnel will refer the patient to a healthcare provider. Facilities must have a system for referring such patients to a healthcare provider when clinically indicated, including when the assessment is either “Probably Benign,” “Suspicious,” or “Highly Suggestive of Malignancy.” (21 CFR 900.12(c)(2)(ii)).
What should patients do if they do not receive their written results within 30 days?
If a patient does not receive their written summary of the results within 30 calendar days, they should contact the mammography facility or their healthcare provider to request the summary of the results of the exam. This is very important. If the issue is not resolved, the patient should file a consumer complaint with the facility's accreditation body (see the Mammography Program Referral List).
Are there special considerations for reporting results when they are "Suspicious" or "Highly Suggestive of Malignancy"?
Yes. In these cases, the facility must provide the written summary of the results to the patient within seven calendar days of the final interpretation of the mammogram. (21 CFR 900.12(c)(2)). Some facilities may discuss the results with the patient following the exam or contact the patient by phone. Even if the results are given to the patient verbally, the patient must receive the written summary of the results within seven calendar days of the final interpretation if the assessment of the mammography report is Suspicious or Highly Suggestive of Malignancy.
How can patients get their "original" mammograms (x-rays)?
Original mammograms are especially important when the mammogram was performed using screen-film technology. However, most mammograms today use digital technologies such as Full-Field Digital Mammography (FFDM) or Digital Breast Tomosynthesis (DBT). For these digital technologies, identical copies can be provided, while the original images are kept by the performing facility, so digital originals are usually not transferred.
If patients need original screen-film mammograms, they can request them from the facility, or have someone else make the request. They can ask the facility to send the original mammograms either temporarily or permanently to another medical facility, their doctor, or to themselves. The facility may ask the patient to fill out a form to release the medical records. If the facility charges a fee for this service, the fee must not be more than it costs them (i.e., the documented costs) to provide this service. (See 21 CFR 900.12(c)(4)(ii), (iii), & (iv)).
For example, patients who had a screen-film mammogram may request their original mammogram if they:
- Change mammography facilities
- Make an appointment for a second mammographic opinion, or an appointment with a surgeon, oncologist, or radiation therapist
- Need earlier mammograms to compare with current ones
What should a patient do if their facility refuses to permanently transfer the original mammograms and other medical records to another facility or to their doctor?
This question only arises for screen-film mammograms, as most mammograms today use digital technologies (FFDM or DBT). If a patient has a complaint, they should first file it with the facility's accreditation body listed on the MQSA certificate. If the accreditation body is unable to resolve the complaint, it will refer the case to the FDA or the State Certifying Agency.
Some facilities may claim that State or local law require them to retain permanent records, but this practice is contrary to the MQSA regulations. If the facility has a signed statement from the patient requesting the transfer of records, the facility will not be cited under MQSA for failure to retain the records.
What is a mammography facility?
A mammography facility is a hospital, outpatient department, clinic, radiology practice, mobile unit, an office of a physician, or other facility that conducts breast screening or diagnosis through mammography procedures.
Do patients need to have a doctor or other healthcare provider refer them to a mammography facility?
A patient can have a mammography exam and receive the follow-up report without a doctor's or provider's referral. This is known as "self referral." Before an exam, a patient should verify that the facility accepts self-referred patients because some facilities do not.
What does certification mean?
Certification means that a mammography facility has been MQSA certified and is capable of providing quality mammography. Certification is issued by the FDA or, for facilities located in the States of Illinois, Iowa, South Carolina, or Texas, by the respective State's FDA-approved Certification Agency.
A facility that is certified has either:
- Completed a rigorous review of its practices by an FDA-approved accreditation body, or
- Is undergoing the process of accreditation by one of the three accreditation bodies.
The three accreditation bodies are the:
- American College of Radiology
- State of Arkansas
- State of Texas
For more information, visit Facility Accreditation and Certification.
Do the three FDA-approved accreditation bodies have the same requirements for quality mammography?
Yes. Patients can be assured that all mammography facilities accredited by any FDA-approved accreditation body are held to the same quality standards. Each accreditation body has met the same stringent FDA requirements for approval. The name of your facility's accreditation body can be found on the MQSA certificate at the facility.
Are all facilities practicing mammography now certified?
All facilities subject to MQSA should be either certified for three years or provisionally certified while they undergo accreditation review. Not all facilities that apply for accreditation meet the quality standards. If a facility is not certified, it must stop providing mammography.
What is a provisionally certified facility?
A provisionally certified facility has had its application accepted by an FDA-approved accreditation body, and the quality aspects of the facility are under review. A provisional certificate is valid for up to six months.
How can a consumer verify that a facility is certified to perform quality mammography?
Search a list of FDA-certified mammography facilities by State or ZIP Code.
At the facility, patients should look for the MQSA certificate indicating that they are in a certified mammography facility. The certificate should be prominently displayed. All certificates have an expiration date, and only facilities with a valid (unexpired) certificate can lawfully provide mammography services. Patients should first inform the facility and then report it to the accreditation body listed on the certificate if the facility is displaying an expired certificate.
What should a consumer do if they find that their facility is no longer providing mammography services?
They should contact the facility, if possible, and request that the facility transfer their original mammograms and other associated records to a certified mammography facility, their physician, or themselves. This transfer of X-rays and records is important because the interpreting physician compares the new mammograms with old ones to see if there have been any changes.
If it is not possible to contact the facility (for example, they have gone out of business), the consumer can contact the MQSA Hotline at 1-800-838-7715 for assistance in trying to obtain their images or records.
What is a serious complaint?
A serious complaint is defined as a report of an event that may significantly compromise the clinical results of a mammography exam or an event for which a facility fails to take appropriate corrective action in a timely manner. Examples of serious complaints include:
- Poor image quality
- Use of radiologists or other facility personnel who don't meet MQSA standards
- Failure to notify patients of exam results within 30 days
- Failure to transfer original mammograms upon request of the patient or their representative.
What should consumers do if they have serious concerns about the quality of their exam?
If a consumer has a serious concern about the quality of their mammogram, they should first contact the complaint coordinator at the facility. If they are not satisfied with the response, they should request the name and phone number of the contact person at the facility’s accreditation body. If contacting the accreditation body does not resolve the issue, they can contact the FDA or the FDA-approved Certification Agency that certifies the facility.
FDA Contact Information
MQSA Hotline 1-800-838-7715
Division of Mammography Quality Standards
Office of Radiological Health
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-3621B
Silver Spring, MD 20993
If a facility is located in Illinois, Iowa, South Carolina, or Texas, consumers should contact the State’s certification agency rather than the FDA. Each of these States is an FDA-approved Certification Agency and is responsible for certifying all mammography facilities within the respective State.
Facilities certified by States may send the above information to:
State of Iowa
Bureau of Radiological Health
Iowa Department of Public Health
Lucas State Office Bldg., 5th Floor
321 East 12th Street
Des Moines, Iowa 50319
Phone: 515-281-3478
State of Illinois
Illinois Emergency Management Agency, Bureau of Radiation Safety
Division of Registration and Certification
1035 Outer Park Drive
Springfield, IL 62704
Phone: 217-785-9923
State of South Carolina
SC DHEC Bureau of Radiological Health
301 Gervais Street
Columbia, SC 29201
Phone: 803-545-4435
State of Texas
Texas Department of State Health Services
Radiation Control Program MC 2835
P. O. Box 149347
Austin, Texas
Phone: 512-834-6688
Who are the complaint contacts at the accreditation bodies?
Please refer to the FDA's Mammography Program Referral List for the names, addresses and phone numbers of the accreditation body complaint contacts.
Should a patient with breast implants have a mammography exam to look for breast cancer?
Yes, patients with breast implants who are in the age group recommended for routine screening can effectively have mammograms. (Those who have had implants as reconstruction after breast cancer surgery on both breasts should ask their doctors to determine if mammograms are still necessary.) When scheduling an appointment, patients should:
- Inform the facility that they have breast implants
- Ask if the facility has personnel with training and experience in implant imaging and interpretation.
Skilled personnel will use special techniques to include as much breast tissue as possible.
If the facility does not have personnel trained in implant imaging, patients should request a referral to another facility.
Should mammograms be used to detect breast implant rupture?
Although implant rupture can sometimes be seen by mammography, when possible, silicone implant rupture is typically evaluated by magnetic resonance imaging (MRI). MRI has been approved by the FDA for detecting rupture or leaks.
Information for Mammography Facilities
Do mobile mammography facilities meet the same requirements as stationary facilities?
Yes. MQSA requirements apply to all mammography facilities. The same standards for image quality apply to both stationary and mobile facilities. Mobile facilities must prominently display an FDA certificate.
Does the FDA inspect mammography facilities?
Yes. The FDA implemented annual inspection of all mammography facilities in 1995. The agency has trained State and FDA inspectors to perform these inspections.
What will happen if there is a problem at a facility?
If the FDA or a State Certification Agency determines that problems at a mammography facility could significantly affect the quality of the images and results, the facility or Certification Agency will notify patients and their providers. Poor-quality mammograms can lead to incorrect exam results. The mammography facility or Certification Agency will usually contact patients and providers by letter.
What information will be in the letter telling patients about problems at a facility?
The letter usually will tell the patient what happened at the facility and what they should do for medical follow-up. For example, the patient may be advised to have their mammogram reevaluated or to have a repeat mammogram.
Will Medicare still pay for mammography performed at facilities that are not MQSA-certified?
No, because such a facility is operating illegally. Furthermore, the FDA has asked other insurance carriers not to pay for mammography performed at uncertified facilities. Consumers should call the Medicare Hotline at 1-800-Medicare (1-800-633-4227) for information about coverage for mammography services. The Centers for Medicare & Medicaid Services (CMS) oversees Medicare. They can also contact their personal insurance carrier about coverage for mammography services.
Will Medicaid still pay for mammography services performed at facilities that are not MQSA-certified?
No, because they are operating illegally. The Centers for Medicare & Medicaid Services (CMS), which oversees Medicaid, alerted State Medicaid Directors to avoid paying claims to mammography facilities that are not MQSA-certified. Patients may wish to call the local Medicaid office for more information.
Are Veterans Administration facilities required to meet the standards of MQSA?
Veterans Health Administration (VA) facilities are exempted from MQSA. However, the VA has initiated its own quality mammography program with standards as strict as those required by MQSA. All VA facilities are required to be accredited by the American College of Radiology. They are also inspected annually by MQSA-trained inspectors.
How can a patient locate the nearest VA mammography facility?
The Women Veterans Call Center (WVCC) receives and responds to questions from women Veterans, their families, and caregivers across the nation about available VA services and resources. The phone number for the WVCC is 1-855-VA-WOMEN or 1-855-829-6636. The WVCC operates Monday through Friday from 8:00 a.m. to 10:00 p.m. ET and on Saturday from 8:00 a.m. to 6:30 p.m. ET.
Information about the MQSA
What is the Mammography Quality Standards Act?
The Mammography Quality Standards Act requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options, and increased chances of survival. Under the law, all mammography facilities must: 1) be accredited by an FDA-approved accreditation body, 2) be certified by the FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) prominently display the certificate issued by the agency.
What standards are mammography facilities required to meet for FDA certification?
The FDA, along with the National Mammography Quality Assurance Advisory Committee, developed comprehensive regulations (issued on October 28, 1997) that became effective on April 28, 1999. The regulations apply to the following:
- Personnel: Physicians who interpret mammograms, radiologic technologists who perform mammography, and medical physicists who survey equipment must have adequate training and experience.
- Quality Control/Record-keeping: Each facility must have an effective quality control program and maintain certain records.
- Medical Audit: Each facility must have a system to collect and review outcome data for all mammographic examinations performed and for obtaining biopsy results.
The standards also require that facilities undergo annual inspections by the FDA or State inspectors who must successfully complete the FDA training program designed specifically for mammography facility evaluation.
Has MQSA improved mammography quality?
Yes. According to the October 1997 report to Congress by the General Accounting Office (now the Government Accountability Office), MQSA positively impacted the quality of mammography services. The report identified two main reasons for these quality improvements:
- Many facilities previously failed to follow voluntary standards or guidelines.
- The FDA's annual inspection process provides a valuable, systematic means of helping to ensure that these higher standards are maintained.
While many facilities had to improve their services to meet the MQSA standards, very few facilities had to close for failing to meet the standards. In most instances, those facilities that closed were located within five miles of another certified facility, indicating that women could continue to have access to mammography services at that time. In some cases, closed facilities either merged with another facility or contracted with mobile service providers to continue serving their patients.
How are mammography patients affected by the MQSA regulations?
The FDA, along with the National Mammography Quality Assurance Advisory Committee, developed comprehensive regulations that became effective on April 28, 1999. Those regulations, published in the October 28, 1997, Federal Register, replaced the interim regulations under which facilities had previously operated.
The current regulations include the following areas of importance for patients:
- Mammography facilities are required to provide patients with written results of their mammograms in language that is easy to understand.
- A consumer complaint mechanism is required to be established in mammography facilities to provide patients with a process for addressing their concerns.
- Patients can obtain their original mammograms, not copies, when they are needed.
- For cases in which a facility's mammograms are determined to be substandard and a risk to public health, facilities will notify the patients and their doctors and suggest an appropriate plan of action.
A subsequent rule amending the MQSA regulations was published in the Federal Register on March 10, 2023. Starting September 10, 2024, mammography facilities must comply with all the requirements, including the breast density notification.
The updated regulations are intended to expand the information required to be shared with patients and healthcare professionals, allowing for more informed medical decision-making. Helping to promote patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.
- The final rule includes new mammogram reporting requirements that require mammography facilities to inform patients and their healthcare providers of the patient's breast density, creating four categories for reporting breast tissue density in the medical report that is sent to the healthcare provider.
- “The breasts are almost entirely fatty.”
- “There are scattered areas of fibroglandular density.”
- “The breasts are heterogeneously dense, which may obscure small masses.”
- “The breasts are extremely dense, which lowers the sensitivity of mammography.”
- The lay language summaries that facilities provide to patients must include a message written in easy-to-understand terms, that shares their breast density and encourages them to speak with their healthcare provider. For example:
- Not dense: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."
- Dense: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."
- Under the final rule, medical reports to healthcare providers and patient summaries must include expanded information about the mammography facility, including the name and address, to better facilitate communication with and among mammography facilities.
- The final rule also codifies three additional categories for the assessments of mammograms that have already been approved by the agency as alternative standards so that facilities can more precisely classify and communicate mammographic findings to healthcare providers:
- Known Biopsy Proven Malignancy – for known malignancies being mammographically evaluated for definitive therapy.
- Post Procedure Mammogram for Marker Placement – for a mammogram taken following a biopsy to confirm the deployment and position of a breast tissue marker.
- Incomplete: Need prior mammograms for comparison – for examinations where comparison with prior mammograms should be performed before an assessment category can be given.
Existing classifications prior to these amendments included: negative, benign, probably benign, suspicious, highly suggestive of malignancy, and incomplete: need additional imaging evaluation.
- These new requirements increase the clarity of communication between mammography facilities, healthcare providers, and patients, and help ensure that healthcare providers and patients obtain the necessary information from the mammography facility to enable a patient and their healthcare provider to make informed medical decisions.
Media Related Calls
Congressional Inquires
- Contact FDA’s Office of Legislation
Complaints
About facilities operating without an FDA certificate:
- The FDA MQSA Hotline – 1-800-838-7715
About a mammography facility's services:
- Contact the facility's accreditation body. The three accreditation bodies and their contacts are:
The American College of Radiology
Theresa Branham
Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Reston, VA 20191-4397
Fax: (703) 648-9176
mamm-accred@acr.org
The State of Arkansas
Melinda Davis, Program Leader, or
Sherry Davidson, Health Physicist
Arkansas Department of Health
4815 W. Markham, Slot H-30
Little Rock, Arkansas 72205-3867
Phone: 501-661-2301
The State of Texas
Kaye Jividen or Jo Turkette
Texas Department of State Health Services
Radiation Control Program MC 2835
P. O. Box 149347
Austin, Texas
Phone: 512-834-6688
Requests for AHCPR Mammography Publications
- AHRQ (Agency for Healthcare Research & Quality) Publications Clearinghouse 1-800-358-9295
Breast Implant Information
- The FDA Breast Implant Information Line – 1-888-463-6332