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The X-ray machine staff of the North Dakota Radiation Control Program conduct activities associated with machine produced ionizing radiation. A major responsibility is the registration and inspection of X-ray machine facilities, equipment, operators and radiation service providers.
Questions may be addressed to the North Dakota Department of Environmental Quality at 701-328-5166, or firstname.lastname@example.org.
All machine sources of ionizing radiation must be registered with the Department. There are over 700 facilities with approximately 1500 X-ray tubes throughout North Dakota. X-ray machines are utilized in a wide range of activities including industrial (airport baggage surveillance, potato packaging, weld verification), research (spectroscopy, diffraction, fluorescence) and healing arts applications for both human and animal patients.
The North Dakota Radiological Health Rules (NDRHR) contain requirements for All X-ray equipment operated in North Dakota. Inspection compliance is based on these requirements. Inspections are prioritized according to potential impact on public and operator health and safety. Inspection frequency ranges from yearly (mammography facilities) to once every seven years (veterinarian). The lead Federal agency involved with X-ray machines is the US Food and Drug Administration (FDA) as authorized by the Federal Food, Drug and Cosmetic Act of 1973. The FDA provides training, equipment and technical expertise to all State radiation control programs.
The North Dakota Radiation Control Program (RCP) has a contract with the FDA to inspect mammography facilities in North Dakota. The MQSA inspectors must be certified by the FDA. Certification requires 6 weeks training, as well as the passing of both written and performance evaluations. North Dakota has two certified inspectors. To maintain certification, inspectors must perform a minimum of 12 inspections annually and obtain 15 hours of mammography education every three year period. The FDA conducts audit inspections with each inspector on an annual basis. Annual facility inspections have been conducted since 1992.
Installation of Radiation Producting Machines
Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines shall be submitted to the Department for review and approval (North Dakota Radiological Health Rules; Subdivision 33.1-10-06-03.2.a). If warranted, the Department may require the applicant to utilize the services of a qualified expert to determine the shielding requirements.
A Radiation Machine Registration - Department of Health"Change of Status Notification" form shall be completed and forwarded to the Department at:
Radiation Control Program
North Dakota Department of Environmental Quality
4201 Normandy Street
Bismarck, ND 58503-1324
The Department may require an additional radiation shielding evaluation, if warranted, prior to approval.
Registration of Radiation Producing Machines
Apply to the Department for registration of a Radiation Machine.
Within thirty (30) days following the installation of a radiation machine, the owner, (i.e., "registrant") of the radiation machine shall make application to the Department for registration. If the equipment is leased, the Department considers the person in possession of the machine to be the "registrant" and responsible for compliance with the North Dakota Radiological Health Rules (NDRHR). You may obtain a "Radiation Machine Registration Form"(SFN-8428).
Complete registration form and remit fee.
Instructions, for completing the registration form, and a schedule of fees is located on the registration form. The application shall be signed and dated by the person responsible for compliance with the NDRHR. The fees are for each machine and cover a three-year registration period, the initial/renewal fee is the amount listed. Remittance shall be included with the registration application and made payable to the North Dakota Department of Health at the address indicated on the registration form.
Issuance of a certified copy of the registration.
Following Department review and approval of registration, the registrant is issued a certified copy of the registration and a registration tab to be affixed to the control console of the X-ray machine. For new registrants the Department also issues a copy of the NDRHR.
The Department will inspect the facility for compliance with the NDRHR. Due to our workload, it is not possible to give an estimated date for inspection of any individual facility. We will contact the facility in advance to schedule the inspection with the registrant. Inspections consist of policy and procedure review, equipment testing and records review.