Section 370.145  Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Entity

Mobile mammography facilities that operate in Illinois and are certified under MQSA by the FDA, or another state authorized by FDA to certify mammography facilities under MQSA, shall:

a)         Notify the Agency by telephone, facsimile or letter of each date and location of operation of the mobile mammography facility in Illinois prior to conducting such operation.

            AGENCY NOTE:  Notifications submitted by the mobile mammography facility to the Agency may contain notice of multiple dates and locations of operation by the mobile mammography facility.

b)         At all times while operating in Illinois, have the following documentation available for review and inspection by the Agency:

1)         A copy of the mammography facility certificate issued by the FDA or another state, showing that the facility is currently certified.

2)         A summary of the most recent physics survey of the mammography machine and documentation of any corrective actions recommended by the medical physicist who performed the physics survey.

3)         Documentation that personnel meet the qualifications of Section 370.70 of this Part.

(Source:  Amended at 29 Ill. Reg. 20963, effective December 16, 2005)