Section 325.5610. Supplemental machine information; effect of failure to submit information.

                      (1) Upon notice from the department that an application for mammography authorization  is   complete  and  complies  with  these  rules  and  at  the  specific  request  of  the department, the applicant shall, within 45 days of the department's request, provide all of the following information for each radiation machine for which mammography authorization is

being sought:

(a)     Confirmation that a department-approved mammography phantom is on-site when mammography is performed and is used in the facility's ongoing quality control program.

(b)  Processor or laser film printer quality control data and corrective actions, if any, taken as a result of that data for a 30-day period beginning after the date the application was sent to the department.

(c)    An x-ray image of a department-approved mammography phantom which is taken during the 30-day period for which processor quality control data is required under subdivision

(b)   of this subrule. The phantom image shall be taken using routine machine settings being used by the facility for that mammography machine for a 4.2-centimeter compressed breast of average density. The phantom image shall be accompanied by documentation of the date that the image was taken and the machine settings that were used.

(d)   Determinations of the half-value layer, radiation exposure at skin entrance, and mean glandular dose that are made with the use of a department-approved dosimetry device exposed on the phantom during the same exposure of the phantom that is used to produce an x-ray image to be submitted under subdivision (c) of this subrule or that are made by other methods as specified or approved by the department.

(e)   A set of clinical images produced on or after the date that the application was sent to the department. Mammography images shall be without pathology for each of 2 representative patients, 1 with dense breasts and 1 with fatty breasts. Stereotactic breast biopsy images shall be from 1 calcification biopsy case that demonstrates accurate needle location and includes the case’s corresponding mammograms.  The submitted images shall meet all of the following:

(i)   The cases are examples of the facility’s best work.

(ii)   The images are from actual patients.

(iii)     Both screen-film and digital images are labeled with the identification information required in R 325.5657 for mammography images or R 325.5683 for stereotactic breast biopsy images.

(iv)   The lead interpreting physician reviews and approves the clinical images.

(2)     The department may waive the requirements of subrule (1) of this rule if the mammography machine is accredited, or is in the process of becoming accredited, by the American college of radiology. To have the requirements of subrule (1) of this rule waived, an applicant shall provide, to the department, within 45 days of the department's request, copies of the applicant's current accreditation application, current accreditation-related correspondence to and from the American college of radiology, or current accreditation certificate that is issued by the American college of radiology.

(3)   Failure of an applicant to submit the information required by the provisions of either subrule (1) or (2) of this rule within 45 days of the department's request may be considered a basis for withdrawal or denial of the mammography authorization, unless the time limit is extended by the department for cause.

History: 1993 AACS; 2013 AACS.