Section 216.2b. Reporting and recordkeeping requirements for registered radiation-producing machine service providers

(a) A radiation-producing machine service provider who installs, services, sells, leases or otherwise transfers a radiation producing-machine or major X-ray system component in this Commonwealth shall submit information to the Department and maintain records as described in this section.

(1) The following information shall be submitted in writing to the Department within 15 days of the action:

(i) The date of installation, service or transfer.

(ii) The name, address, telephone number and registration number, if registered, of the client facility.

(iii) The type of radiation-producing machine, the manufacturer’s name, model number and control panel serial number of each radiation-producing machine, or major X-ray system components involved in the transaction.

(iv) A contact name of the individual for the service action.

(2) A copy of the assembler’s report on United States Food and Drug Administration (FDA) Form 2579, prepared in compliance with the Federal diagnostic X-ray standard (21 CFR 1020.30(d)(1) (relating to diagnostic x-ray systems and their major components)), when completed in full and submitted to the Department within 15 days following the service, satisfies the requirements of paragraph (1) and subsection (d) for services provided under the assembler’s report.

(b) Services performed under preventative maintenance that do not involve replacement or refurbishing of major X-ray system components are exempt from the reporting requirements specified in this section except subsection (d).

(c) A radiation-producing machine service provider shall maintain a log or other record of radiation-producing machines installed or serviced in this Commonwealth. The record shall be maintained for 5 years for inspection by the Department and shall list the following information:

(1) The date the machine was installed or service provided.

(2) The name of the customer, address, telephone number and customer’s State registration number.

(3) The type of radiation-producing machine, the manufacturer’s name, model number and control panel serial number of each radiation-producing machine or major X-ray system component involved.

(4) The name of the individual performing the service.

(d) A radiation-producing machine service provider who services a radiation-producing machine in a radiation installation in this Commonwealth that is not registered shall report the service to the Department. The report shall be submitted in writing within 15 days after the services and contain the following information:

(1) The date service was provided.

(2) The name, address and telephone number of the client.

(3) The type of radiation-producing machine, the manufacturer’s name, model number and control panel serial number of each radiation-producing machine or major X-ray system component.

(4) The name of the individual performing the service.

The provisions of this § 216.2b adopted July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823.

Notation

Authority

The provisions of this § 216.2b issued under sections 301 and 302 of the Radiation Protection Act (35 P. S. § § 7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20).

Cross References

This section cited in 25 Pa. Code § 216.6 (relating to transfer and disposal obligations).