Breast Health - MQSA
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Mammography Facilities Must Meet Quality StandardsOn October 1, 1994, the United States Congress approved the Mammography Quality Standards Act (MQSA) that requires mammography facilities to adhere to strict quality standards. MQSA was created by the U.S. Food and Drug Administration (FDA) and requires any facility that provides mammograms to: be accredited by the FDA or an FDA-approved accreditation body, be certified by the FDA or the State, receive annual MQSA inspections, and display its FDA certification in a prominent area. On April 28, 1999, the final comprehensive regulations for mammography facilities went into effect. The regulations were developed by the FDA and the National Mammography Quality Assurance Advisory Committee and approved by President Clinton. The following regulations are required of every mammography facility in the United States:
How Do the FDA Regulations Affect Women Who Receive Mammograms?Mammography facilities are now required to provide patients with written results of their mammograms in easy-to-understand language within 30 days of the mammogram. Patients may also obtain their original mammogram (not a copy) from the facility so they may compare the results with previous mammograms. Self-referred patients with no designated healthcare provider will receive both the simplified report and the report designated for the physician. For cases in which an abnormality is detected on the patient’s mammogram, the facility is required to notify the patient and her physician (if appropriate) and recommend a suitable course of action. The American College of Radiology (ACR) has established the Breast Imaging Reporting and Database System (BI-RADS) to help radiologists read mammograms. Click here for more information on mammography levels and the BI-RADS mammography reporting system. Note: Women who do not receive their mammogram results within 30 days should contact the mammography facility and ask for the results. Women should not assume their mammogram is normal if they do not receive the results. Frequently Asked Questions About Mammography Facilities(1)
What is a Mammography Facility?The FDA has defined a mammography facility as any facility that conducts breast screening or diagnosis through mammography procedures. These facilities include: hospitals, outpatient departments, clinics, radiology practices, mobile units, or physicians’ offices. How Many Mammography Facilities are FDA-Approved?As of June 27, 2001, there were 9,646 MQSA-certified mammography facilities in the U.S. and its territories. Of these, 315 are in the process of receiving accreditation. Do Mammography Facilities Require Women to be Referred by their Physicians?Women do not need to by referred by a physician in order to have a mammogram at most facilities. Women who do not have a primary physician or do not wish to be referred by their physician may "self-refer" themselves at most facilities. Before the mammogram, women should verify that the facility accepts self-referred patients. What does FDA Certification of a Mammography Facility Mean?All mammography facilities must be certified by the FDA or an FDA approved accreditation body. Certification means that a mammography facility has met the MQSA requirements for providing quality mammography. The five FDA approved accreditation bodies are: the American College of Radiology, the State of Arkansas, California, Iowa, and Texas. Do the Five FDA Approved Accreditation Bodies Hold the Same Requirements for Mammography Facilities?Yes, all five FDA approved accreditation bodies have met the same FDA requirements necessary to approve mammography clinics. Can Other States Become Certifiers of Mammography Facilities?In June 1996, the FDA established a States as Certifiers (SAC) Working Group to develop procedures and regulations to transfer the process of certifying mammography facilities from the FDA to applicant states. Final regulations are expected to go into effect in 2002 which was allow application states to:
As of June 6, 2001, 45 states and jurisdictions have contracts with the FDA to perform annual MQSA inspections. What is a "Provisionally Certified" Facility?A provisionally certified facility has had its application approved by an FDA accreditation body and will remain under review for six months before receiving full certification. Provisionally certified facility may legally perform mammograms. Are All Mammography Facilities Currently FDA Certified?All mammography facilities should be FDA certified except Veteran’s Administration (VA) facilities. The MQSA certificate indicating that the facility is FDA certified should be clearly displayed. Patients should note the expiration date on the certificate. All mammography facilities must meet the same quality standards to receive certification. Only Veteran’s Administration (VA) facilities are exempt from MQSA requirements. However, VA facilities have their own strict standards for ensuring quality facilities. All VA facilities must also be accredited by the American College of Radiology and are subject to annual MQSA inspections. Patients may locate the nearest VA facility by calling 1.888.492.7844 Monday through Friday 8:00 a.m. to 4:30 p.m. Eastern time.
Yes, facility certification can now be extended to include FDA-approved digital mammography units. The FDA uses a technology system called the Mammography Program Reporting and Information System (MPRIS) to track certification activities and other aspects of the MQSA program.
Certified inspectors of mammography facilities carefully:
How Can a Woman Locate a Nearby FDA Certified Mammography Facility?The Center for Devices and Radiological Health of the FDA maintains an extensive Mammography Site Database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmqsa/search.cfm. Women may search for a nearby mammography clinic by entering their state and zip code. Click here for more information on the FDA Mammography Site Database.
Absolutely. Under the MQSA, a facility must keep mammography films and reports in a medical record for no less than five years, or no less than 10 years if a patients has had no other mammograms at that facility; however, this period could be longer if mandated by state or local law. Facilities must allow transfer of a patient's medical record to her, to the mammography facility where she will receive future mammograms, or to her referring physician. Facilities must also grant a request for permanent or temporary transfer of a medical record made by the patient or by someone acting on her behalf. Lastly, facilities must limit any fee charged to the patient for transferring her patient record to the documented cost of the service. Mammography facilities are not required to keep medical records on patients imaged before October 1, 1994 when the rule became effective. However, state or local regulations may require otherwise.
If a patient's mammography facility closes, the FDA will notify the patient by letter and outline the facility's responsibilities under MQSA. The closing facility must submit a plan for storing or distributing medical records, and the plan must be approved by the FDA. For example, facilities no longer performing mammography can store medical records in a hospital or appropriate warehouse.
The FDA website (http://www.fda.gov/cdrh/mammography/) publishes reports of facility performance under MQSA inspection. These reports list all adverse facility performances including the revocation of medical licenses at mammography facilities, warnings or actions taken against mammography facilities, the reason for warnings or actions, corrective actions, and the status of these facilities. The FDA website also includes reports on mammography from the U.S. General Accounting Office (GAO). Additional Resources and References
Updated: April 2005 |
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