The Mammography Quality Standards Act (MQSA) (Revised 12-12-19)
Modified on: Thu, 12 Dec, 2019 at 5:02 PM
Developed in 1987 by the ACR Task Force on Breast Cancer, the accreditation program is the country’s first and the largest for mammography. The program is directed by radiologists and medical physicists on the Committee on Mammography Accreditation of the ACR Commission on Quality and Safety. As an ACR peer-review program, all reports, documentation, correspondence (including e-mail) between the ACR and the facility undergoing accreditation, and any information provided by the facility to evaluate its imaging services is privileged and confidential under the Code of Virginia 8.01-581.17. (The facility name, address, phone number, and listed contact personnel are not considered privileged and confidential).
The success of the ACR program in improving the quality of mammography motivated the U.S. Congress to model the provisions of its 1992 Mammography Quality Standards Act (MQSA) after the ACR’s Mammography Accreditation Program. MQSA requires that all mammography facilities in the United States except those of the Veterans Administration be:
Accredited by an approved body
Certified by the U.S. Department of Health and Human Services (HHS), and
Inspected by the HHS (or a state agency acting on behalf of the HHS)
The U.S. Food and Drug Administration’s (FDA) MQSA regulations define a mammography facility as “a hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities.” The following MQSA milestones impacted all mammography facilities:
October 1, 1994 - all mammography facilities in the U.S. were required to be MQSA-certified; a facility without a current MQSA certificate performing mammography after this date is practicing unlawfully and may be subject to FDA sanctions and fines
October 28, 1997 - FDA published the Mammography Quality Standards; Final Rule
April 28, 1999 - the Final Rule went into effect
October 28, 2002 - more stringent equipment regulations went into effect
The FDA has approved the ACR as an accrediting body for screen-film, full-field digital mammography (FFDM) and digital breast tomosynthesis systems (see the FDA’s Digital Accreditation webpage for a current list of accrediting bodies approved by the FDA).
The accreditation program requirements outlined on this site are identical or equivalent to those in the FDA Final Rules. ACR recommendations for improved quality are clearly designated as such but are not required for accreditation.
The best source of clarification or assistance regarding the FDA’s Mammography Quality Standards Final Rule is the FDA. For policy questions, you should check the FDA’s Policy Guidance Help System. This guidance reflects FDA’s current thinking on the final regulations implementing MQSA. You may also call the FDA Facility Hotline at (443) 285-0689 or email them at MQSAhotline@versatechinc.com. Current data on the number of MQSA-certified facilities and units may be obtained from the FDA website. In addition, the ACR recommends that facilities familiarize themselves with the FDA website to gain knowledge of what is expected, and to maintain up to date information about MQSA. Here are some other helpful links from the FDA website:
The ACR’s Mammography Accreditation Program website provides a link to a Checklist of MQSA Requirements for Mammography Equipment for your medical physicist, as well as a document detailing MQSA Personnel Requirements.
Mammography Units Used Exclusively for Stereotactic Breast Biopsy
Although stereotactic breast biopsy procedures do involve radiography of the breast, stereotactic breast biopsy is currently exempt from MQSA regulations. However, any mammography unit or personnel involved, even occasionally, in routine screening or diagnostic mammograms must meet MQSA quality standards. These units must be included in the accreditation process and will be covered under the MQSA certificate. See the FDA’s Policy Guidance Help System and the FDA's guidance on Prohibited Equipment for more information. Uncertified units may be used to produce mammographic images only if they meet all of the following conditions:
The mammographic images obtained are an integral part of the stereotactic breast biopsy procedure.
Facilities must not bill separately for these mammographic images. They must bill only for the stereotactic breast biopsy procedure.
If the mammographic images obtained as part of the stereotactic breast biopsy procedure result in the cancellation of the procedure (e.g., lesion or calcifications no longer seen, calcifications are determined to be in the skin), the facility must not report nor bill the attempted procedure as a mammogram, but rather as a canceled procedure.
If the procedure is canceled for reasons described in (3), FDA strongly recommends that the findings (or absence of findings) be confirmed by an immediate follow-up study performed on an MQSA-certified unit. See the FDA Policy Guidance Help System for more information.
Occasionally, practices have reported experiencing payment problems with the CMS for FFDM and/or DBT services. The FDA does not provide MQSA certificates that specifically state that a facility is certified to perform FFDM or DBT. Instead, they send CMS a weekly file containing the most recent approval information. Your payer must look at the current MQSA file to see whether your facility is certified to perform digital mammography or tomosynthesis.
See CMS Transmittal 913 on the handling of these files and provide a copy to your local payer. You may contact the appropriate CMS headquarter representatives:
Medicare Carrier (for non-payment of the professional component)
Medicare Fiscal Intermediary (for non-payment of the technical component)
Please provide them with your facility’s 6-digit FDA ID number from your MQSA certificate and your MQSA expiration date.
If you continue to have problems after contacting the above individuals, please contact the ACR Economics Department for assistance at (800) 227-5463.
Revision History for this Article
Description of Revision(s)
Article created; FAQs incorporated; No criteria changes
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