Section 325.5612. Notice of change in application information; authorization not transferable.  


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  •                       (1) A facility that is authorized to perform mammography shall notify the department,  in  writing,  of   any  change  in   the  information   contained  in  the  application  or supporting  material  upon  which  authorization  was  granted  or  any  change  that   affects  the accuracy of information which is provided or obtained during the application and evaluation process  for   authorization.                      Changes  that  shall   be  reported  include  changes  in  any  of  the

    following:

    (a)   Facility ownership.

    (b)   Facility location.

    (c)   Mammography machine.

    (d)  Image modality.

    (e)   American college of radiology accreditation status.

    (2)     Upon receipt of a notice of change, the department shall advise the facility if reapplication for mammography authorization, resubmittal of phantom or clinical images, or other actions are deemed by the department to be necessary to establish that the  facility, machine, system, and personnel remain in compliance with the requirements of these rules. Upon department request, a facility shall provide any requested information or materials within 45 days after the request is made.

    (3)     If changes in information are deemed to require reapplication for mammography authorization, the application shall be filed and processed in the same manner as set forth in R 325.5607 and R 325.5608.

    (4)  Mammography authorization that is issued by the department is not transferable between machines or between persons who own or lease a radiation machine.

History: 1993 AACS; 2013 AACS.