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for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
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November 1999
The following Q&As provide background on the Mammography Quality Standards Act (MQSA) and mammography facilities.
Frequently Asked Questions about:
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 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?
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 final regulations apply to the following:
The standards also require that facilities undergo annual inspections by FDA or State inspectors who must successfully complete a 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, MQSA has had a positive impact on the quality of mammography services. The report identified two reasons for the quality improvements:
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. 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.
What is in the future to assure the quality of mammography?
FDA, along with the National Mammography Quality Assurance Advisory Committee, developed comprehensive final regulations that became effective on April 28, 1999, and should lead to further improvements in mammography quality. The final regulations approved by President Clinton and published in the October 28, 1997 Federal Register, replaced the interim regulations under which facilities operated. The Federal Register notice can be found on FDA’s mammography home page at www.fda.gov/cdrh/mammography.
How will mammography patients be affected by the MQSA final regulations?
The final regulations include new areas of importance for patients:
Mammography Facilities
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.
Does a patient need to have a doctor refer her to a mammography facility?
No. She can have a mammography exam and receive the follow-up report without a doctor’s referral. (This is known as "self referral.") Before her exam, she should verify that the facility accepts self-referred patients because some facilities do not.
Certified Facilities/Certificates
What does certification mean?
Certification means that a mammography facility has been MQSA certified and is capable of providing quality mammography. 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 five accreditation bodies. The accreditation bodies are the American College of Radiology, and the States of Arkansas, California, Iowa, and Texas.
Do the five FDA-approved accreditation bodies have the same requirements for quality mammography?
Yes. A woman can be assured of receiving the same quality mammography from all facilities accredited by any FDA-approved accreditation body. 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?
They are supposed to be. All facilities 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 fails accreditation, 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 patient verify that a facility is certified to perform quality mammography?
To find FDA-certified mammography facilities in your area, click on "Certified Facilities" from the options on your left -- you will need to scroll to the top of this page to see the menu.
At the facility, the patient should look for the MQSA certificate indicating that she is 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.
Closed Mammography Facilities
What should a patient do if she finds that her facility is no longer providing mammography services?
She should contact the facility, if possible, and request that her original mammograms and other associated records be transferred to a certified mammography facility, to her physician, or to herself. The x-rays and records should be transferred because new mammograms are compared with old ones to see if there have been any changes.
Mobile 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 all facilities, whether stationary or mobile. Mobile facilities must prominently display an FDA certificate.
Veteran’s Administration Facilities
Are Veteran’s Administration facilities required to meet the standards of MQSA?
Veteran’s Administration (VA) facilities are exempted from MQSA. However, 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?
She should call the Mammography Help Line for the Veteran’s Administration. The toll-free number is 1-888-492-7844. It is available Monday through Friday, 8:00 a.m. to 4:30 p.m. Eastern Time. Messages can be left after hours and calls will be returned. Representatives of the VA will help callers locate a VA facility. They will also answer questions about the VA mammography program.
Inspections
Does FDA inspect mammography facilities?
Yes. FDA began annual inspection of all mammography facilities in 1995. The agency has trained State and FDA inspectors for this purpose.
Payment
Will Medicare still pay for mammography performed at facilities that are not MQSA-certified?
No, because such a facility is operating illegally. Furthermore, FDA has asked other insurance carriers not to pay for mammography performed at uncertified facilities. Patients should call the Medicare Hotline at 1-800-638-6833 for information about coverage for mammography services. They can also contact their personal insurance carrier about coverage for mammography services. The Centers for Medicare & Medicaid Services (CMS) oversees Medicare.
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.
Mammogram (General)
What is a mammogram?
A mammogram is a safe, low-dose x-ray picture of the breast. It is currently the most effective method of 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 a breast lump early may mean that a patient can choose surgery to save her 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 women do not find a mammogram exam painful for the short time needed to take the picture.
Should women 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. MQSA has established a maximum radiation dose limit that is considered to be safe. There have been such improvements in mammography that women receive 50 times less radiation than they received 20 years ago, with the risk of long-term effects being almost zero.
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 a 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 physician trained to read the mammograms examines them later. Screening for breast cancer is best achieved by including both mammography and a clinical breast examination in the screening process.
What is a diagnostic mammography exam?
A doctor uses a diagnostic mammogram to help learn the cause of a woman’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.
Notification of Mammography Exam Results
How will a patient get the results of her mammogram?
Her mammography facility must provide her with a written report of the results of the exam. The results can be handed to her at the time of the exam, or mailed to her within 30 days after the exam. The report must be in words she can easily understand. Her doctor will be sent a copy of the more technical version of the exam results.
How will patients who do not have a doctor get their results?
Her mammography facility will provide her 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 her to a doctor.
What should a patient do if she does not receive her written results within 30 days?
If she does not receive her results within 30 days, she should call the mammography facility or her doctor, 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 she does not receive her results!
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 contact the patient as soon as possible. Although it is impossible to establish a precise time frame, it is expected that such communication could ordinarily be accomplished within five business days. Some facilities may discuss the results with the patient following the exam, or contact her by phone. Even if the results are given to the patient verbally, she should receive a written notification within 30 days.
Obtaining Original Mammograms
How can patients get their "original" mammograms (x-rays)?
She can ask -- or have someone else ask – the facility for her original mammograms and a copy of the medical report. She can ask the facility to send them either temporarily or permanently to another medical facility, to her doctor, or to herself. Her facility may ask her 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 needs her original mammograms if she decides to:
How can a patient make sure that her "original" mammograms are being transferred instead of "copies" of them?
When requested by the patient (or by someone acting on her 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.
What should a patient do if her facility refuses to permanently transfer her original mammograms and other medical records to another facility or to her doctor?
She 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 FDA.
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.
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.
Consumer Complaints
What should patients do if they have "serious" concerns about their exam?
If a patient has a serious concern about her mammography exam, she should ask to talk to the complaint contact person at the facility. If she is not satisfied, she should ask the facility for the name and phone number of the contact person at their accreditation body. If she contacts her accreditation body and still feels she is not satisfied, she can contact the U.S. Food and Drug Administration at 301-594-3332, or the address below:
Center for Devices and Radiological Health
Office of Communication, Education, and Radiation Programs
Division of Mammography Quality and Radiation Programs (HFZ-240)
Rockville, Maryland 20850
What is a serious complaint?
A serious complaint is defined as a report of an event that significantly compromises the clinical results of a mammography exam, and/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) missed cancers; 3) the use of radiologists or other facility personnel that don’t meet MQSA standards; 4) failure to notify patients of the results of their exam within 30 days; or 5) failure to transfer original mammograms.
Who are the complaint contacts at the accreditation bodies?
Please refer to "FDA’s Mammography Program Referral List" for the names, addresses and phone numbers of the accreditation body complaint contacts.
Notifying Patients of Adverse Events
What will happen if there is a problem at a facility?
If MQSA inspectors find problems at a mammography facility that could significantly affect the quality of the x-rays and the results, the facility or FDA will notify patients and their physicians. A poor quality mammogram can mean the exam results might be wrong. The mammography facility or FDA will usually contact patients and physicians 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 she should do for medical follow-up. For example, the patient may be asked to have a follow-up mammogram.
Breast Implants
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 she schedules her appointment, she should do two things:
Skilled personnel will use special techniques that expose 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, implant rupture is being evaluated by magnetic resonance imaging (MRI). MRI has been approved by FDA for detecting rupture or leaks.
FDA’s Mammography Program
Definitions
Congress passed the Mammography Quality Standards Act to ensure that mammography performed at the approximately 10,000 facilities in this country is safe and reliable. The law was passed to assure high 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. Women 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 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 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 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.
Reinstated Certificate: FDA may issue a "reinstated certificate" to facilities that were formerly provisionally certified but denied full accreditation because of problems in meeting MQSA standards. Such facilities either corrected the problems or submitted a plan of correction, and have applied once again for accreditation. A reinstated certificate is 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 be conducting mammography.
FDA’S Mammography Program
Referral List
MEDIA RELATED CALLS
CONGRESSIONAL INQUIRIES
COMPLAINTS
About facilities operating without an FDA certificate:
About a mammography facility’s services:
The American College of Radiology
Priscilla F. Butler, M.S.
Director, Breast Imaging Accreditation Program
American College of Radiology
1891 Preston White Drive
Reston, VA 20191
Phone: 800-227-6440
The State of Arkansas
Jared Thompson, Health Physicist Supervisor, or
Caroline Hibbs, Health Physicist
Arkansas Department of Health
Division of Radiation Control and
Emergency Management
4815 W. Markham Street, Slot 30
Little Rock, Arkansas 72205
Phone: 501-661-2173
The State of California
Bonnie Bessemer
Mammography Accreditation Program
Radiologic Health Branch, M/S 178
P O Box 942732
Sacramento, CA 94234-7320
Phone: 916-445-7116
Back-up – Maureen Long, 916-327-1034
The State of Iowa
Donald A. Flater, Chief
Bureau of Radiological Health
Iowa Department of Public Health
401 SW 7th Street, Suite D
Des Moines, Iowa 50309
Phone: 515-281-3478
The State of Texas
Kaye J. Goss-Terry or Jo Turkette
Texas Department of Health
Texas Mammography Accreditation Program
1100 West 49th Street
Austin, Texas 78756
Phone: 888-899-6688
REQUESTS FOR AHCPR MAMMOGRAPHY PUBLICATIONS
BREAST IMPLANT INFORMATION
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