Draft Revisions to Mammography Rules (Posted 6/18/2012)

The Radiation Safety Section is proposing revisions to Part 14 – Mammography of the Ionizing Radiation Rules. The draft revisions to Part 14 are available for review on our website.

Under the State of Michigan's formal rule promulgation process, the department is required to hold a public hearing to receive comments from interested stakeholders. At this time we have not set a date for the public hearing. This notification is intended to provide all mammography registrants and other interested parties adequate time to review the new rule draft prior to the formal announcement of the public hearing.

Background

The current mammography rules were added to the Ionizing Radiation Rules on November 12, 1993. Subsequent to that date the federal Mammography Quality Standards Act (MQSA) final rules took effect and set minimum standards that all mammography facilities must follow. Although federal mammography standards exist, the Department believes it is important for Michigan to retain its own set of mammography standards in case the federal standards are not reauthorized by Congress.

The proposed changes to Part 14 will update the current rule set to be more consistent with the federal MQSA regulations and will add appropriate requirements for the use of digital mammography machines. In addition, the proposed changes would add requirements for stereotactic breast biopsy consistent with the recommendations of the American College of Radiology (ACR).

Discussion

Updating the rule set will be accomplished by adding new rules, amending existing rules, and deleting unnecessary rules. The rule set will also be reorganized as necessary. Proposed changes to Part 14 include:

  • Replacing most of the current definitions with the definitions of the MQSA regulations. Definitions necessary for the implementation of statutory authority will be retained.
  • Replacing the concept of the mammography supervisor in the existing rules with the lead interpreting physician requirements of the MQSA regulations.
  • Replacing most of the interpreting physician requirements with the requirements of the MQSA regulations.
  • Replacing the mammography machine operator requirements with the radiologic technologist requirements of the MQSA regulations.
  • Replacing the radiation physicist requirements with most of the medical physicist requirements of the MQSA regulations.
  • Replacing most of the mammography machine equipment requirements with the equipment requirements of the MQSA regulations.
  • Replacing most of the quality control requirements with the quality assurance requirements of the MQSA regulations. This will add requirements for digital mammography which the current rule set does not address.
  • Adding new rules to address personnel, equipment, medical records and reports, quality assurance, medical outcomes audit, and consumer complaints for stereotactic breast biopsy.
  • Adding new rules to address the availability of referenced MQSA and ACR documents, retention of personnel records, consumer complaints, and processing of mammography images within 24 hours.

Next Steps

In the next several weeks we intend to set a date for the formal public hearing. We will respond and potentially make changes to the draft based on comments received at the public hearing. The hearing will be announced in three state newspapers and via the section's listserv. Instructions for subscribing to the section's listserv can be found on our website at www.michigan.gov/rss.

Questions or comments concerning this information should be sent to T.R. Wentworth at wentwortht@michigan.gov.