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On April 17, 2013, revised rules Part 14 – Mammography were filed with the Office of the Great Seal and became effective immediately. A copy of the new rules is available on our website. The major changes to the rules are to make the mammography requirements more consistent with the federal Mammography Quality Standards Act (MQSA) and to add requirements for stereotactic breast biopsy.
Here are some changes to the rules that will affect your mammography program:
If your facility has a stereotactic breast biopsy (SBB) add-on device for a mammography machine, the machine will have to be authorized for both mammography and SBB. Because no SBB add-on devices are currently authorized, your facility will have to obtain separate authorization for stereotactic breast biopsy. An application for authorization for a SBB add-on device must be submitted within 90 days of the effective date of the new rules. Please contact the Radiation Machine Registration Unit at 517-241-1989 or email@example.com to obtain an application for authorization. To be authorized to perform SBB, the machine must meet the SBB accreditation criteria of the American College of Radiology (ACR). To demonstrate compliance with this requirement, you need to submit evidence of current accreditation or go through a Department evaluation of compliance with the ACR SBB criteria. More information about authorization can be found on our website.
If your facility has a prone stereotactic breast biopsy table, authorization will need to be obtained under the new rules when the current authorization expires. The authorization process for mammography machines will not change.
There are new requirements for SBB radiologic technologists and medical physicists; x-ray equipment; medical records and SBB reports; and quality assurance.
The concepts of the mammography supervisor and the medical director for the delivery of mammography services have been replaced with the lead interpreting physician requirements of the MQSA. The Department will no longer require monthly on-site visits by the medical director for the delivery of mammography services. The Department will no longer require semi-annual performance evaluations of the radiologic technologist by the mammography supervisor.
Most of the MQSA regulations for the qualifications of mammography interpreting physicians have been adopted by reference, except that physicians must be board certified within 2 years of becoming eligible. The board certification requirement has always been enforced in Michigan. The continuing experience requirement will now be 960 mammographic examinations in the prior 24 months.
The MQSA requirements for radiologic technologists have been adopted by reference. The Department will no longer approve mammography technologist training courses to be used in lieu of the advanced certificate in mammography.
The MQSA requirements for medical physicist have been adopted by reference. The Department will no longer issue certificates of approval as a mammography physicist. Physicists who had valid state approval certificates prior to the effective date of the new rules will be approved in lieu of board certification. After the effective date of the rules, new physicists will have to qualify under the MQSA.
More information about the revised mammography rules can be found on our website at www.michigan.gov/rss.