R 333.5605 Standards for authorization.

Rule 605. The department shall issue a 3-year mammography authorization if the mammography facility is in compliance with all of the following standards: (a) The radiation machine meets any of the following requirements: (i) The machine and the facility in which the machine is used meet the criteria for the American college of radiology mammography accreditation program dated January 2014, and the facility submits an evaluation report issued by the American college of radiology as evidence that the criteria are met. The criteria are adopted by reference in these rules for the purpose of applying this paragraph only. (ii) A machine used for stereotactic breast biopsy and the facility in which the machine is used meet the criteria of the American college of radiology stereotactic breast biopsy accreditation program dated July 2013, and the facility submits an evaluation report issued by the American college of radiology as evidence that the criteria are met. The criteria are adopted by reference in these rules for the purpose of applying this paragraph only. A mammography machine that uses a specially designed add-on device for breast biopsy shall be authorized for both mammography and stereotactic breast biopsy. (iii) The machine is used in a facility that has successfully completed the department's evaluation of the items described in R 333.5610. (b) The radiation machine, the film or other image receptor used with the machine, and the facility where the machine is used meet the requirements of this part and applicable provisions of these rules. (c) The radiation machine is specifically designed to perform mammography. (d) The radiation machine is used exclusively to perform mammography. (e) The radiation machine is used in a facility that, before the machine is used on patients and at least annually thereafter, has a qualified medical physicist provide on-site consultation to the facility as described in these rules. (f) The radiation machine is used according to R 333.5667 or R 333.5690 for stereotactic breast biopsy. (g) The radiation machine is operated only by an individual who can demonstrate to the department that he or she meets the standards described in this part.