There are times in the operation of every mammography facility when questions come up regarding maintaining compliance with the Mammography Quality Standards Act (MQSA) of 1992 and its implementing regulations at 21 CFR § 900, or about other mammography-related topics. The Food and Drug Administration’s (FDA) Division of Mammography Quality Standards (DMQS) has a significant amount of information on the MQSA website to assist facilities in their efforts to ensure that safe and effective mammography services are provided, and to keep the public and healthcare providers informed of MQSA program activities and policies. The following brief descriptions highlight some of the information that can be found on the MQSA website.

CMS Reimbursement - Facilities seeking resolution to Medicare reimbursement denials should contact the Centers for Medicare and Medicaid Services (CMS) directly. CMS is the federal agency responsible for Medicare reimbursements, and every week DMQS sends a file with updated certification data to CMS. Contact information for CMS is located on the MQSA website on the CMS Reimbursement Issues page.

Adding a Digital Breast Tomosynthesis (DBT) Unit – A facility interested in adding a DBT unit to its mammography practice must apply to its accreditation body to receive accreditation for the Full Field Digital Mammography (2D) component of the mammography unit and then apply for a certificate extension from the FDA for the DBT component of the mammography unit, PRIOR to imaging patients using DBT technology. A list of FDA-approved accreditation bodies and their telephone numbers is available on the Accreditation Bodies page. Facilities interested in viewing a list of digital mammography units cleared for use in the United States, or in instructions for the FDA certificate extension application process (including a pdf fillable application form), should take a look at the Digital Accreditation webpage of the FDA’s MQSA website. A facility must possess a letter from FDA approving its certificate extension to include the use of a DBT unit for EACH DBT unit PRIOR to using that unit to image patients.

EQUIP – On October 27, 2016, to coincide with the beginning of the 25th year since the passage of the MQSA, DMQS launched the EQUIP initiative – Enhancing Quality Using the Inspection Program. A video of the EQUIP presentation given by Helen Barr, M.D., Director of DMQS, to the National Mammography Quality Assurance Advisory Committee, is available for review. Additionally, Dr. Barr has posted a message to mammography facilities, in the form of a MQSA Insight Article, regarding EQUIP. Facility personnel can also refer to the Frequently Asked Questions (FAQs) for the EQUIP initiative for additional information. In addition, a new video is now available for viewing. The video depicts a mock inspection close out session at a facility and discusses what the inspector is looking for, and not looking for, related to the EQUIP questions. Both videos and all EQUIP information can be found on the Inspection News page of the MQSA Website.

Inspection Fees – Facilities in need of information regarding inspection fees or the MQSA billing process can find that information on the Facility Certification and Inspection (MQSA): Inspection Fees page.

MQSA Hotline - If you cannot find answers to your MQSA questions on the MQSA website, or if you would like to suggest a topic to be covered in a future MQSA communication, you can direct your questions, or suggestions, to the MQSA Facility Hotline. Facilities can send an e-mail to [email protected], or call the Hotline at 1-800-838-7715.

MQSA Insight Articles – Posted on the MQSA website are a series of short articles that cover important mammography topics. These articles are designed to help facilities improve the quality of mammography by allowing them to see how facilities in the aggregate are doing across the nation, as well as through exploring specific mammography topics. In addition to the EQUIP topic discussed above, the posted MQSA Insight Articles to date include such topics as, The Annual MQSA Inspection: What Facilities Can Do To Help; Poor Positioning Responsible for Most Clinical Image Deficiencies, Failures; PACS: An Ounce of Prevention...; Printers and the Evolution of Mammography. Additional articles are on the MQSA Insights Articles page.

MQSA Updates – Updates to the MQSA website can be sent directly to the computers or smart phones of facilities and individuals. To subscribe to the electronic listserv and receive e-mail alerts and highlights of updates to the MQSA website as they become available, go to the FDA’s Email Updates page.

Policy Guidance Help System (PGHS) - The PGHS provides useful information to mammography facilities and their personnel, and provides answers to questions that have been posed by mammography facilities. The content of the PGHS is organized in broad topics that are easy to identify and allow the viewer to drill down to more specific information. Topics such as Accreditation and Certification, Personnel Qualifications, Quality Control and Quality Assurance, Medical Records and Medical Reports are all discussed in the PGHS. You may view the PGHS by going to the Policy Guidance Help System page.

Search for an MQSA Certified Facility – Consumers and healthcare providers can search for a certified facility by State or by ZIP Code using the FDA database accessible on the Mammography Facilities page.

Additional Resources

The NIH National Cancer Institute has a website where healthcare professionals and patients can find additional information on breast cancer screening, prevention, treatment, and research.

The creation of the Office of Women's Health (OWH) in 1994 by the Food and Drug Administration established a new chapter in the agency's commitment to women's health issues. Since its creation, OWH has established itself as an effective voice for women's health concerns.

The Society of Breast Imaging (SBI) was founded in 1985 to: 1) improve and disseminate knowledge in the field of breast imaging; 2) improve the quality of medical education in the field of breast imaging; 3) foster research in all aspects of breast imaging; 4) provide a medium for the exchange of ideas among professionals involved with breast imaging; 5) provide meetings for presentation and discussion of papers and the dissemination of knowledge in the area of breast imaging, and 6) establish a channel for publication of scientific reports in the field of breast imaging.

Veterans Health Administration (VHA) voluntarily participates in the MQSA program by requiring its facilities to be accredited by the American College of Radiology and annually inspected by FDA-trained MQSA inspectors. VA medical centers have a Women Veterans Program Manager to help these veterans access VA benefits and health care services. To identify VA facilities near you, call the Women Veterans Call Center (WVCC) at 1-855-VA-WOMEN or 1-855-829-6636, or visit the VHA locations page.