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Planning or Starting Up a New X-ray Facility
Michigan's Ionizing Radiation Rules Governing the Use of Radiation Machines establish radiation safety requirements for new and existing radiation facilities that use x-ray equipment or other ionizing-radiation-producing equipment. The Radiation Safety Section in the Michigan Department of Licensing and Regulatory Affairs is responsible for enforcing these Rules.
When planning or starting up a new facility that will use a radiation machine, the following information should be helpful to ensure compliance with the Rules:
Registration of Radiation Machines
Radiation Shielding Plan Review and Approval
Authorization of Mammography Machines
Personnel Radiation Monitoring
Radiation Machine Operator Training
Some Related Requirements of Other Regulatory Programs
Online Payment of Registration or Inspection Fees
Contacts, Questions, or Requests for Additional Information:
If there are regulatory questions about the planning or start up of a new radiation facility or questions concerning the Rules, e-mail inquiries may be sent to firstname.lastname@example.org.
Click here for phone numbers and for street addresses of our Lansing headquarters or Detroit district office, including a map to our Lansing headquarters.
Registration of Radiation Machines: X-ray machines and other ionizing-radiation-producing machines are required by Rule 37 to be registered with the Radiation Safety Section in the Michigan Department of Licensing and Regulatory Affairs. Registration by the owner or user of radiation equipment is required by law prior to use of a radiation machine.
Registration can be completed online at: https://aca3.accela.com/MIHS/
Radiation Shielding Plan Review and Approval: Many types of radiation machines require specially shielded rooms or areas to protect the machine operator and others who may be nearby. The degree of protection required for an enclosure for a radiation machine is subject to design approval by the Radiation Safety Section, pursuant to several rules.
Radiation shielding plan review approval for the following types of machines and uses should be obtained from the Radiation Safety Section prior to construction of an x-ray room, prior to submitting plans to a local building department, and prior to operation of the radiation machine.
Types of radiation machine uses for which shielding design plans should be submitted to the Radiation Safety Section for review and approval include:
Medical/podiatric/chiropractic/veterinary use of x-ray equipment
- Stationary radiographic or fluoroscopic x-ray machine
- CT scanner
- Mammography machine
- Mobile x-ray machine used routinely in one location
- Linear accelerator or other therapy x-ray machine
Dental use of x-ray equipment
- Cephalometric x-ray machine
- Dental CT or tomographic x-ray machine
Industrial/educational/governmental use of x-ray equipment
- Radiographic or fluoroscopic x-ray machine used in a medical, dental, industrial, or other type of training facility for machine operators or radiographers
- Industrial x-ray equipment that is not totally shielded by the equipment design (self-shielded).
Radiation Shielding Plan Reviews can be completed online at: https://aca3.accela.com/MIHS/ and should be submitted to the Radiation Safety Section as part of the plan review and approval process. Please include a floor plan or construction plans with your submittal to the Radiation Safety Section to show proposed radiation shielding and the design layout of the x-ray room. If there is potential occupancy above or below the x-ray room, include construction details for the ceiling and floor and other specific information.
Click here for some general radiation shielding design guidance from the Radiation Safety Section for many common types of x-ray facilities.
Authorization of Mammography Machines: Prior to use of a radiation machine for mammography, Rule 605 of the Rules requires specific authorization to be granted by the Radiation Safety Section in the Michigan Department of Licensing and Regulatory Affairs. Mammography machine registration must be completed online. The first step is to complete an initial Radiation Machine Registration application. Once the application has been received and reviewed a mammography machine authorization application will be sent to your account as a temporary record. The mammography machine authorization application must be completed and a Mammography Machine Authorization Application Attestation form uploaded. Once we have received the completed Radiation Machine Registration Application and payment of fee, the Authorization application and supporting documentation, the information will be reviewed and processed. A Radiation Machine Registration Certificate will be issued with an authorization expiration date and information on the next steps in the process.
Mammography facilities are required to comply with the applicable portions of Part 135 of the Public Health Code, Act 368 of 1978 as amended, and with Part 14 of the Rules. Screening and diagnostic mammography facilities are also subject to the requirements of the federal Mammography Quality Standards Act, including the requirement to have mammography machines accredited by the Mammography Accreditation Program of the American College of Radiology.
Personnel Radiation Monitoring: Facilities are required by the Rules to provide personnel monitoring to operators of many types of radiation machines. Personnel monitoring is typically required for operators of:
- Medical/podiatric/chiropractic/veterinary x-ray machines
- Industrial/educational/governmental radiographic or fluoroscopic machines, accelerators, x-ray diffraction or fluorescence analytical machines, and certain production gauges
- Machines operated by students in educational or training facilities
Form MIOSHA-RSS-837 lists a number of companies providing personnel radiation-monitoring services.
Radiation Machine Operator Training: Prior to use of a radiation machine, an operator shall receive adequate training and instruction in the safe use of the equipment and other related aspects, as described in Rule 93 of the Rules and as may be described in other applicable rules.
For operator training in mammography facilities, see Part 14 of the Rules for additional training, certification, and continuing education requirements. Screening and diagnostic mammography facilities are also subject to the operator training requirements of the federal Mammography Quality Standards Act.
For operator training in computed tomography (CT) facilities, see Part 15 of the Rules for additional training, registration, and continuing education requirements.
Some Related Requirements of Other Regulatory Programs:
Certificate of Need Section: Some radiation machines and radiological services are also subject to Certificate of Need (CON) approval. Radiation machines and services currently subject to CON approval include: CT scanners, x-ray machines used in heart catheterization procedures or in lithotripsy procedures, and therapy accelerators. For such machines that are also subject to CON approval, the Radiation Safety Section will withhold issuing a registration to permit the use of such a radiation machine until both of the following have occurred:
- The CON Section has approved a CON for that machine and service, and
- The Radiation Safety Section has reviewed and approved radiation-shielding plans for the room in which the radiation machine will be used
Health Facilities Engineering Section: A radiation machine may be intended for installation in a portion of a Licensed Health Care Facility that is undergoing significant new construction or modernization. If the new construction or modernization project in a licensed hospital has a capital expenditure of $1,000,000 or more, or a project in a freestanding surgical outpatient facility has a capital expenditure of $50,000 or more, then the Health Facilities Engineering Section is responsible for general project plan review and for the approval of the project design and construction. Applicable types of licensed health care facilities regulated by the Health Facilities Engineering Section include, but are not limited to, hospitals, nursing homes, and freestanding outpatient surgical facilities. Plan review and approval by the Radiation Safety Section is also required in such facilities for the rooms and areas that will contain radiation machines.
Last updated: 11/15/2019