R 333.5604 Department inspections.

Rule 604. (1) The department shall inspect a mammography machine and system not later than 60 days after initial mammography authorization is issued. After that initial inspection, the department shall annually inspect the mammography machine and system. The department may inspect more frequently than annually. (2) After a satisfactory inspection by the department, the department shall issue a certificate of radiation machine inspection which identifies the facility and the machine inspected and which provides a record of the date that the machine was inspected. The facility shall conspicuously post the certificate on or near the inspected machine and in a location that is observable by patients. (3) The department may issue a notice of violations certificate if violations found during an inspection are not corrected within the specified time limit or if the department has not received written verification of corrections within the specified time limit. The notice of violations certificate shall be conspicuously posted on or near the inspected machine and in a location observable by patients. (4) A facility shall remove the certificate of radiation machine inspection if directed by the department due to subsequent failure to comply with these rules as determined by follow-up inspections by the department. (5) In conducting inspections, the department shall have access to all equipment, materials, records, personnel, and information that the department considers necessary to determine compliance with these rules. The department may copy, or require the facility to submit to the department, any of the materials, records, or information considered necessary to determine compliance with these rules. (6) The department shall designate department employees to conduct regulatory inspections. (7) The department may conduct tests and evaluations as the department considers appropriate to determine compliance with all of the provisions of these rules. MAMMOGRAPHY AUTHORIZATION