REQUIREMENTS FOR STEREOTACTIC MAMMOGRAPHIC EQUIPMENT

Subpart 1. Equipment requirements. Radiation-producing equipment specifically designed to perform stereotactically guided breast biopsies must meet the requirements of this chapter and: A. nationally recognized standards such as Code of Federal Regulations, title 21, section 1020; B. the equipment manufacturer's specifications; or C. part 4732.1100 . Subp. 2. Registrant requirements. The registrant must ensure that: A. individuals operating the equipment meet the requirements of Minnesota Statutes, section 144.121 , subdivision 5, or the Food and Drug Administration's Mammographic Quality Standards Act requirements; B. individuals have completed equipment manufacturer's training or equivalent and initial site-specific training in the registrant's operating and emergency procedures; C. the training in item B is documented and records kept; and D. the entire system for stereotactic breast biopsies including the equipment performance, procedures, and records are evaluated annually by a diagnostic radiographic physicist. Subp. 3. Quality assurance and quality control procedures. The registrant must ensure that: A. all manufacturer's quality assurance or quality control procedures follow the test procedures established by the registrant, recommendations of a nationally recognized standard, or the manufacturer's specifications; B. the frequency of the quality assurance or quality control procedures, and corrective actions as a result of quality control testing are followed and documented; and C. the facility's operating and emergency procedures include quality assurance or quality control procedures. Subp. 4. Records. Records must be maintained according to part 4732.0330 .