On March 10, 2023, the FDA issued the Final Rule to Amend the MQSA Regulations. These updated requirements are to be implemented within 18 months after publication in the Federal Register. As noted in the final rule, the FDA concluded that 18 months was a practical timeframe for facilities to implement these requirements without undue hardship. Facilities are not precluded from including the required breast density notification prior to 18 months; however, facilities subject to MQSA must comply with all the requirements, including the breast density notification, no later than September 10, 2024. The information on this webpage will be updated further when the amended MQSA regulations go into effect.
The following Q&As provide background on the Mammography Quality Standards Act (MQSA) and mammography facilities.
- Breast Implants
- Certified Facilities/Certificates
- Closed Mammography Facilities
- Consumer Complaints
- Mammogram (General)
- Mammography Facilities
- The Mammography Quality Standards Act
- Mobile Facilities
- Notifying Patients of Adverse Events
- Notification of Mammography Exam Results
- Obtaining Original Mammograms
- Veterans Health Administration Facilities
- Referral List
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 for following up on mammograms that reveal problems, 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 had already had a positive impact on the quality of mammography services. The report identified two reasons for the 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.
Many facilities had to improve their services to meet the MQSA standards, but 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. It was further noted that, in some cases, closed facilities either merged with another 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 published in the Federal Register on March 10, 2023. These new regulations are required to be implemented within 18 months after their publication in the Federal Register. As noted in the final rule, the FDA concluded that 18 months was a practical timeframe for facilities to implement these requirements without undue hardship. Facilities are not precluded from including the required breast density notification prior to 18 months; however, facilities subject to MQSA must comply with all the requirements, including the required breast density notification, no later than 18 months after the date of publication.
The updated regulations are intended to expand the information required to be shared with patients and health care 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 also include a message written in easy-to-understand terms sharing their breast density and encouraging them to speak with their healthcare provider. For example:
- "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."
- "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 health care providers and patient summaries also need to 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" - reserved for known malignancies being mammographically evaluated for definitive therapy.
- "Post Procedure Mammogram for Marker Placement" - reserved for a mammogram taken following a biopsy to confirm the deployment and position of a breast tissue marker.
- "Incomplete: Need prior mammograms for comparison" - reserved 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.
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: 1) completed a rigorous review of its practices by an FDA-approved accreditation body; or 2) is undergoing the process of accreditation by one of the three accreditation bodies. The accreditation bodies are the American College of Radiology, and the States of Arkansas and Texas.
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 that are 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?
A list of FDA-certified mammography facilities that is searchable using State or ZIP Code is available at http://www.fda.gov/findmammography, or click on "Search for a Certified Facility" from the options on the left — scroll to the top of this page to see the menu.
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.
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, to their physician, or to 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.
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 all facilities, whether stationary or mobile. Mobile facilities must prominently display an FDA certificate.
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.
Does 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.
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.
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 easiest to cure. In some cases, finding breast cancer early may mean that a patient can choose surgery to save their breast. Early detection also may mean that chemotherapy is unnecessary.
How is a mammogram done?
When you have a mammogram, you stand in front of a special x-ray machine. The radiologic technologist lifts each breast and places it on a platform that holds the x-ray film. The breast is then gradually pressed against the platform by a specially designed, clear plastic plate. Some pressure is applied for a few seconds to make sure the x-rays show as much of the breast as possible. This pressure is not harmful to your breast. Studies show that most patients do not find a mammogram exam painful for the short time needed to take the picture.
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, easy way to detect breast cancer early when treatment is more effective and survival is high. It is an x-ray of the breast that doctors use to look for breast changes in women with no symptoms of breast cancer. Usually, two x-ray pictures are taken of each breast. A qualified physician trained to read the mammograms examines 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 check 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 report of the results of the exam. The results can be handed to the patient at the time of the exam, or mailed to the patient within 30 days after the exam. The report must be in words a patient can easily understand. The patient's doctor or healthcare provider will be sent a copy of the more technical version of the exam results.
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 version 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.
What should patients do if they do not receive their written results within 30 days?
If a patient does not receive their results within 30 days, they should call the mammography facility or their healthcare provider, and ask for the results of the exam. This is very important. The results of most mammograms are "normal" — but the patient should not assume the mammogram is normal if they do not receive their results. If the patient cannot get their problem resolved, they should make a consumer complaint to the facility's accreditation body (see the Mammography Program Referral List below).
Are there special considerations for reporting results when they are "suspicious" or "highly suggestive of a malignancy"?
Yes. In these cases, the facility is expected to provide the written report to the patient within seven days after the mammogram is interpreted. 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, in these suspicious or highly suggestive cases the patient should receive a written notification within seven days of the interpretation.
How can patients get their "original" mammograms (x-rays)?
Original mammograms are especially important when the mammogram was performed using screen-film technology. Today, however, most mammograms are performed using digital technologies (Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT)), not screen-film. 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 ask -- or have someone else ask -- the facility for their original mammograms and a copy of the medical report. They can ask the facility to send the original mammograms either temporarily or permanently to another medical facility, to their doctor, or to the patient. 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 to provide this service.
A patient who had a screen-film mammogram needs their original mammograms if they decide to:
- change mammography facilities,
- make an appointment for a second mammographic opinion, or an appointment with a surgeon, oncologist, or radiation therapist, or
- needs earlier mammograms to compare with current ones.
How can a patient make sure that their "original" mammograms are being transferred instead of "copies" of them?
This issue only matters for screen-film mammograms. Today, most mammograms are digital (FFDM or DBT), and copies are identical and are as good as the originals. If a patient's mammograms were performed as screen-film, then when requested by the patient (or by someone acting on their behalf), the facility is obligated by law to send the original mammograms for temporary or permanent transfer. Personnel at the receiving facility will usually be able to tell if the films are copies of screen-film mammograms.
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, but most mammograms today are digital (FFDM or DBT), not screen-film. They may file a complaint 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 claim they are bound by State or local law to retain permanent records, but this practice is contrary to the MQSA regulations. If the facility has a signed statement by the patient requesting the transfer, the facility will not be cited under MQSA for failure to retain the records.
What are appropriate charges for the transfer of mammography records and can the facility charge the cost of making copies of the films to the patient?
Appropriate charges for transfer of mammography records could include: 1) administrative costs incurred in logging in the request, 2) retrieving the appropriate films and reports, 3) having the patient sign a release (if not already done), 4) packaging and mailing charges for the materials, 5) and photocopying costs incurred in making copies of report.
When transferring original screen-film mammograms, facilities may, but are not required to, make copies of the mammography films. If these copies are requested by the patient or are mandated by State regulations, then the cost of making the copies can be charged to the patient. If the facility wishes to keep copies for its own benefit, the cost cannot be charged to the patient.
Facilities must be able to produce, if requested by the patient, documentation (an itemized bill, for example) that the charges do not exceed the costs associated with this service.
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 contact the complaint coordinator at the facility. If they are not satisfied, they should ask the facility for the name and phone number of the contact person at their accreditation body. If they contact the accreditation body and still are not satisfied, they can contact the U.S. Food and Drug Administration or the FDA-approved Certification Agency which certifies the facility.
FDA Contact Information
Division of Mammography Quality Standards
Office of Radiological Health
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
MQSA Hotline 1-800-838-7715
If a facility is located in Illinois, Iowa, South Carolina, or Texas, a consumer should contact the State rather than the FDA,, since each of these States is an FDA-approved Certification Agency and is responsible for certifying all 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
State of Illinois
Illinois Emergency Management Agency, Bureau of Radiation Safety
Division of Registration and Certification
1035 Outer Park Drive
Springfield, IL 62704
State of South Carolina
SC DHEC Bureau of Radiological Health
301 Gervais Street
Columbia, SC 29201
State of Texas
Texas Department of State Health Services
Radiation Control Program MC 2835
P. O. Box 149347
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: 1) poor image quality; 2) the use of radiologists or other facility personnel who don't meet MQSA standards; 3) failure to notify patients of the results of their exam within 30 days; or 4) failure to transfer original mammograms upon request of the patient or their representative.
Who are the complaint contacts at the accreditation bodies?
Please refer to "FDA's Mammography Program Referral List" below for the names, addresses and phone numbers of the accreditation body complaint contacts.
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 the results, the facility or Certification Agency will notify patients and their providers. A poor quality mammogram can mean the exam results might be wrong. 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.
Should a patient with breast implants have a mammography exam to look for breast cancer?
Yes, patients with breast implants who are in an age group for which routine screening is recommended can effectively have mammograms. (Those who have had implants as reconstruction after breast cancer surgery on both breasts should ask their doctors whether mammograms are still necessary.) When a patient schedules an appointment, they should do two things:
- inform the facility that they have breast implants; and
- ask if the facility has personnel with training and experience in implant imaging and interpretation.
Skilled personnel will use special techniques that include as much breast tissue as possible.
If the facility has no personnel trained in implant imaging, ask to be referred 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.
Congress passed the Mammography Quality Standards Act to ensure that mammography performed at the nearly 9,000 facilities in this country is safe and reliable. The law was passed to assure high quality mammography for early breast cancer detection, which can lead to early treatment and increased chances of survival. Under the law, mammography facilities must be MQSA certified as meeting quality standards. Patients should look for the MQSA certificate displayed in each mammography facility indicating that it can lawfully perform mammography. All certificates have an expiration date. Patients should inform the facility first if it is displaying an expired certificate, then report it to the accreditation body listed on the certificate.
Certification means a mammography facility has been certified either by the FDA or an approved State Certification Agency as capable of providing quality mammography. Facilities that are certified have either completed a rigorous review of the standards (called accreditation) or are undergoing that process. To be certified, a facility must: have specific mammography equipment that is periodically surveyed; employ specially trained personnel to administer tests and interpret data; and have a quality assurance program. In addition, each facility must have a system for following up on mammograms that reveal problems, and for obtaining biopsy results. The regulations also require facilities to be inspected annually by the FDA or State inspectors who must successfully complete an FDA training program designed specifically for mammography facility evaluation.
The following terms are used either to describe the types of certificates issued to mammography facilities by the FDA or the status of mammography facilities:
Full Certification: Fully certified facilities that have completed the accreditation review process and have been issued an MQSA certificate that is valid for three years.
Provisional Certification: Provisionally certified facilities that have had their applications accepted by an FDA-approved accreditation body. The quality aspects of the facility remain under review during the six-month period when the provisional certificate is valid.
Reinstatement: A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by the FDA, or that has had its certificate suspended or revoked by the FDA, may apply to have their certificate reinstated. If their application is successful, the FDA would consider them to be a new facility and they would be eligible for a provisional certificate valid for up to six months.
Decertification: Decertification means that the mammography facility has been denied certification and, as such, can no longer legally perform mammography. There are several reasons for decertification, and they are not all related to quality mammography. For example, a facility may have failed to complete the accreditation process, which is a prerequisite for MQSA certification, or may have let their current certification expire. In any case, a decertified facility should not perform mammography.
MEDIA RELATED CALLS
- FDA's Office of Media Affairs:
Hours of Operation: 8:30 a.m. to 5:30 p.m. ET except Federal holidays
FDA Office of Media Affairs
10903 New Hampshire Ave.
Building 32, Room 5245
Silver Spring, Maryland 20993
- FDA's Office of Legislation
Office of Legislation
Office of the Commissioner
10903 New Hampshire Avenue
White Oak 32
Silver Spring, MD 20993
About facilities operating without an FDA certificate:
- FDA's MQSA Hotline – 1-800-838-7715
About a mammography facility's services:
Contact the facility's accreditation body. The three accreditation bodies and the contacts are:
The American College of Radiology
Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Reston, VA 20191-4397
Fax: (703) 648-9176
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
The State of Texas
Kaye Jividen or Jo Turkette
Texas Department of State Health Services
Radiation Control Program MC 2835
P. O. Box 149347
REQUESTS FOR AHCPR MAMMOGRAPHY PUBLICATIONS
- AHRQ (Agency for Healthcare Research & Quality) Publications Clearinghouse 1-800-358-9295
BREAST IMPLANT INFORMATION
- FDA's Information Line - 1-888-463-6332