ACR Mammography Accreditation and MQSA
1
A Survival Toolbox
Passing ACR accreditation and the Mammography Quality Standards Act (MQSA) inspection need not
be a daunting experience. However, it does take routine attention to producing quality mammograms,
constant awareness of the performance of your equipment and chemistry, organizational skills, and
especially knowing where to go for information and guidance. There are currently a number of sources
available for help, whether you prefer reading it on paper, cruising the Web or talking with a living,
breathing human. The following summarizes some of the best sources and how to use them:
American College of Radiology Mammography Accreditation Program
The ACR Web Site [www.acr.org]: This
information-packed Web site is not just for
members only. On the home page, click on
“Departments” and then “Accreditation” to locate
detailed information on any of the ACR’s nine
programs (Mammography, Stereotactic Breast
Biopsy, Breast Ultrasound, MRI, Ultrasound,
Nuclear Medicine, CT, Radiography/ Fluoroscopy
and Radiation Oncology.) Click on
“Mammography” to locate the ACR’s breast
imaging topics such as the Mammography
Accreditation Program Overview, Frequently
Asked Questions, downloadable QC forms from
the 1999 ACR QC Manual, information on
Stereotactic Breast Biopsy Accreditation and
Breast Ultrasound Accreditation, the BI-RADS®
lexicon, and the ACR’s Breast Care Guidelines.
The Frequently Asked Questions are updated
routinely, so be sure to check the Web if you have
questions.
The Mammography Accreditation Information
Line [800-227-6440]: Phones are staffed by
experienced mammography technologists who can
help you with questions on accreditation, the FDA
regulations, or other general mammography or QC
issues.
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The 1999 ACR Mammography Quality Control
Manual: This “cookbook” style manual is still the
best source of information on how to perform and
evaluate the quality control tests required by the FDA
and recommended by the ACR. After publication of
this last revision, the ACR sent one to the supervising
radiologist at each ACR-accredited facility. New
facilities accrediting with the ACR will also receive
one copy. You may purchase additional copies by
contacting ACR Publication Sales at 800-227-7762.
The Food and Drug Administration
The Food and Drug Administration’s MQSA Web
Site [www.fda.gov/cdrh/mammography]: The FDA
has developed an extremely useful and user-friendly
Web site to help mammography facilities understand
the current regulations and implement their
requirements. Both the text of the Mammography
Quality Standards Act and the Final Regulations are
available. They’ve included a new feature called
“Facility Scorecard” that contains inspection results
and national statistics. In addition, you can subscribe
to their Mammography Listserv to receive e-mail
alerts and highlights of their Web site as they become
available.
The FDA’s Policy Guidance Help System: This
question/answer guidance document is updated several
times a year and reflects the FDA’s current thoughts
on the final regulations implementing MQSA.
Although it can be accessed directly through the
FDA’s Web site, it works best when downloaded to
your own computer. (The FDA Web site has easy
instructions for this.) The system is organized as a
series of books or main topics (see the Contents tab to
the left of the figure below). To view the list of topic
titles in a specific book click on the appropriate page
icon. To see the contents of a topic, simply click on its
title.
The FDA Hotline [800-838-7715]: Call this number if you have questions about the FDA
regulations, your facility’s certification or MQSA inspections. You can also fax your question(s) to
410-290-6351 or e-mail them at MQSAhotline@SSSI.net.
C:\Docstoc\Working\pdf\87253f85-2e5d-4cbc-8134-e18af0b7da96.doc Revised: 2/26/03