MQSA and FDA Regulations
General FAQ
- How many MQSA-certified mammography facilities and units are there in the United States?
- How many MQSA-certified full-field digital mammography facilities and units are there in the United States?
- Are there any data showing trends in the number of mammography units and facilities in the United States?
- Where can I go for assistance or clarification of the FDA mammography regulations?
- A facility where I interpret mammograms did not have all of my qualification documentation (e.g., initial qualifications, continuing education, or continuing experience) on location during their MQSA inspection. Will this facility be issued a notification of non-compliance for their personnel not meeting MQSA qualifications, and must I stop interpreting mammograms?
- Is a radiologist required to be onsite when performing a diagnostic mammogram?
- I just had my MQSA inspection. My inspector informed me that I needed to update our Consumer Complaint Policy to provide a timeframe for reporting complaints to the ACR. Does the ACR have a time limit in which we have to report complaints to the ACR?
Q. How many MQSA-certified mammography facilities and units are there in the United States?
A. Current data on the number of MQSA-certified facilities and units may be obtained from the FDA Web site.
Q. How many MQSA-certified full-field digital mammography facilities and units are there in the United States?
A. Current data on the number of MQSA-certified facilities and units may be obtained from the FDA Web site.
Q. Are there any data showing trends in the number of mammography units and facilities in the United States?
A. Yes. Click on the following link for a chart showing the number of MQSA-certified mammography facilities in the United States since 2000. (This chart will be updated annually.)
Q. Where can I go for assistance or clarification of the FDA mammography regulations?
A. The best source of clarification or assistance regarding the FDA Quality Mammography Standards; Final Rule is the FDA. For policy questions, you should check the FDA’s Policy Guidance Help System first.
The FDA’s Policy Guidance Help System reflects FDA’s current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA). The system is organized as a series of books or main topics, and the entire document is searchable and user-friendly.
Facility staff can also call the FDA Facility Hotline at 800-838-7715 or fax your question(s) to them at 410-290-6351.
Q. A facility where I interpret mammograms did not have all of my qualification documentation (e.g., initial qualifications, continuing education, or continuing experience) on location during their MQSA inspection. Will this facility be issued a notification of non-compliance for their personnel not meeting MQSA qualifications, and must I stop interpreting mammograms?
A. The answer depends on the circumstance of the MQSA inspection. If you met all initial and continuing MQSA requirements for interpreting physicians (including having taught or completed 15 Category 1 CME in mammography in the previous 36 months and having interpreted or multi-read at least 960 mammographic examinations during the previous 24 months) but the documentation was not present at the time of the facility’s MQSA inspection, this may be no more than a paperwork issue.
The FDA recommends that MQSA inspectors give facilities five days to provide this documentation; however, inspectors are allowed to use their own discretion in providing this option. Several states have instructed their inspectors to cite facilities if the records are not available at the time of the inspection.) Even if the inspector does give the facility time to get the records, FDA still requires the inspector to give the facility a minor citation (Level 3) for failing to have the records on hand at the time of the inspection. MQSA inspectors usually do notify facilities at least five days in advance of the MQSA inspection. It is prudent to use this advance notice to make sure all documents are available in order to avoid the added costs and time spent trying to resolve this citation once it has been issued.
If you do not meet the MQSA requirement for continuing education or continuing experience, this is not a paperwork issue and, you will need to reestablish your qualifications before resuming independent interpretation at this facility. (Note that if your qualifications and documentation were in order at other facilities that were inspected earlier the same year, you may continue to interpret at those facilities.)The FDA website has guidance on “Reestablishing the Interpreting Physician Continuing Education Requirements” and/or “Reestablishing the Interpreting Physician Continuing Experience Requirement.”
The FDA has written the following useful guide to let facilities know how to get ready for an MQSA inspection: The Mammography Quality Standards Act Final Regulations: Preparing for MQSA Inspections; Final Guidance for Industry and FDA.
Q. Is a radiologist required to be onsite when performing a diagnostic mammogram?
A. No. There is no regulation that requires a radiologist to be present during diagnostic mammography. However, the ACR Practice Guideline for the Performance of Diagnostic Mammography recommends that a radiologist be present since a diagnostic mammogram is performed to provide additional information about an area of concern within the breast. The ACR guidelines are not requirements but are designed as an educational tool to assist practitioners in providing appropriate radiologic care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care.
Q. I just had my MQSA inspection. My inspector informed me that I needed to update our Consumer Complaint Policy to provide a timeframe for reporting complaints to the ACR. Does the ACR have a time limit in which we have to report complaints to the ACR?
A. No. The ACR does not specify a timeframe for facility’s to report unresolved serious consumer complaints because we realize that every complaint is different. The amount of time facility staff will need to spend in an effort to resolve a complaint varies considerably; however, facilities should report unresolved serious consumer complaints to the ACR as soon as possible. See the Mammography Accreditation Program Overview for ACR’s consumer complaint policy.