LEGISLATIVE & REGULATORY AFFAIRS REPORT Richard Martin, Alexandria, VA

FDA Rolls-Out EQUIP Inspection for Mammography Quality

Late last year, the Food and Drug Administration, Division of Mammography Quality Standards (DMQS) launched the Enhancing Quality Using the Inspection Program (EQUIP) initiative. The initiative adds three questions to the inspection to underscore the importance of routine, regular image quality review in keeping mammography quality high. The EQUIP questions are process-focused and designed to gauge whether appropriate procedures are in place for image quality feedback and review. Facilities can tailor these procedures to their needs.

The EQUIP questions are:

1. Does the facility have procedures for corrective action when clinical images are of poor quality?
2. Does the facility have procedures to ensure images continue to comply with clinical image quality standards of the facility's accreditation body?
3. Does the facility have a procedure for interpreting physician oversight of QA/QC records and corrective actions?

While inspections under EQUIP began January 1, 2017, no facility will receive citations related to the EQUIP questions during the first year of the initiative. Inspectors will use this initial year to educate facilities about EQUIP.

DMQS hopes EQUIP will help facilities identify image quality problems early and encourage timely corrective action. For more information, see EQUIP's Website.

NRC Considers Category 3 Protection and Accountability at Public Meeting

The Nuclear Regulatory Commission (NRC) held a public meeting on January 31, 2017 seeking input on potential modifications to Category 3 source protection and accountability requirements. (See meeting notice and request for comment published in the Federal Register on January 9, 2017.)

Category 3, which includes high dose rate (HDR) brachytherapy sources, affects medical use of isotopes. Potential enhancements addressed at the meeting are verification of Category 3 licenses through the License Verification System (LVS), inclusion of Category 3 sources in the National Source Tracking System (NSTS), and expansion of physical security requirements to include Category 3 quantities of radioactive material. The number of licensees impacted would be approximately 5,500. Stakeholders at the meeting told NRC staff that current protections were adequate and little or no benefit would be gained by adopting any of the suggested enhancements. In addition, they expressed concern whether current licensing and source tracking systems would be robust enough to handle the increased volume.

NRC staff will use information gathered at the meeting and in the public comment process to evaluate whether it is necessary to revise NRC regulations or processes governing source protection and accountability. NRC is particularly interested in quantifying any perceived benefit or burden of any actions it may take, and the agency is looking to stakeholders for this information.

AAPM anticipates filing comments by the March 10, 2017 deadline. Let us know if you have any questions on this issue, or if you would like to provide information to include in AAPM's comments. Contact Richard J. Martin, JD, AAPM's Government Relations Specialist (571) 298-1227.

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