Section 322.80  Reporting and Recordkeeping Requirements for Radiation Machine Service Providers

a)         A radiation machine service provider who installs a radiation machine in the State of Illinois must report the installation to the Agency.  [420 ILCS 40/25.2(b)]

1)         A radiation machine service provider shall submit the following information in writing to the Agency within 15 days after installation:

A)        The installation date.

B)        The name, address, telephone number, and registration number of the facility where the radiation machine was installed;

C)        The type of radiation machine, the manufacturer's name, model number and control panel serial number of each radiation machine; and

D)        Name of the individual that installed the radiation machine.

2)         In the case of diagnostic x-ray systems that contain certified components, and in lieu of subsection (a)(1), a copy of the assembler's report on United States Food and Drug Administration (FDA) form 2579, prepared in compliance with requirements of the federal diagnostic x-ray standard (21 CFR 1020.30(d)(2001)), shall be submitted to the Agency within 15 days following completion of the assembly.  Such report, when completed in full, shall suffice in lieu of any other assembly report submitted by the assembler to the Agency.

b)         Radiation machine service providers shall maintain a log or other record of radiation machines installed or serviced in the State of Illinois.  The record shall be maintained for 5 years for inspection by the Agency and shall list the following information:

1)         Date machine was installed or service was provided;

2)         Name of customer, address, telephone number, and customer's radiation installation registration number;

3)         The type of radiation machine, the manufacturer's name, model number and control panel serial number of each radiation machine; and

4)         Name of the individual that installed the radiation machine.

c)         A radiation machine service provider who services a radiation machine in a radiation installation in the State of Illinois that is not registered under Section 24.7 of the Act must report the service to the Agency.  [420 ILCS 40/25.2(c)] The report shall be submitted in writing within 15 days after such service and contain the following information:

1)         Date service was provided;

2)         Name, address, and telephone number of the customer;

3)         The type of radiation machine, the manufacturer's name, model number and control panel serial number of each radiation machine; and

4)                  Name of the individual that serviced the radiation machine.

(Source:  Amended at 32 Ill. Reg. 16759, effective October 6, 2008)