Question: Do I need a license to operate an x-ray machine in the State of Michigan, and are there any other credentials necessary to be the operator of an x-ray machine?
Answer: The State of Michigan does not license the operators of x-ray machines, nor does it have any requirements relative to the licensure or credentialing of x-ray machine operators. However, legislation was enacted in June 1989 which amended the Public Health Code. That legislation specifies that a person who performs mammography in the State of Michigan must be specifically trained in mammography or must be an individual who is a physician. Mammography rules which address the issue of minimum qualifications for mammographers were promulgated on November 12, 1993.
Question: My annual radiation machine registration fees changed from last year's fees. What are the current registration fees, and why have they increased over last year's fees?
Answer: The current annual registration fees are $69.76 for the first dental or veterinary x-ray tube, $38.71 for each additional dental or veterinary x-ray tube, and $116.31 for each nondental or nonveterinary x-ray tube. In accordance with Act 88, P.A. 1992, which amended the Public Health Code, these fees must be adjusted on an annual basis to reflect the cumulative annual percentage change in the Detroit Consumer Price Index, not to exceed 5%.
Question: What are my obligations as an installer of radiation machines in the State of Michigan?
Answer: Pursuant to Part 4 of Michigan's Ionizing Radiation Rules, an installer must file with the Department of Community Health a quarterly report of all radiation machine installations within the state. Installers are responsible for ensuring that their radiation machines are installed to meet all of the applicable requirements of the Ionizing Radiation Rules. In addition, any vendor or installer who demonstrates a radiation machine within the state must register the demonstration machine with the Department and comply with all requirements of the Ionizing Radiation Rules which pertain to the use of such equipment.
Question: What do I need to do before using an x-ray machine in the State of Michigan, and does my x-ray machine require a state inspection by the Radiation Safety Section before being used?
Answer:
Click here for specific information about planning or starting up a new x-ray facility.
All x-ray machines must be registered with the Department of Community Health prior to being put into use. A radiation machine registration application must be completed and returned to the Department with the appropriate registration fee payment. Upon receipt of the completed application and registration fee, the Department will issue a radiation machine registration certificate and radiation machine tag to the registrant, which subsequently allows use of the x-ray machine. Typically, the Radiation Safety Section does not conduct an inspection of an x-ray facility prior to registration or initial use of the x-ray equipment.
Question: What is required if an x-ray machine is moved from it's current address to a location at another address?
Answer: Relocating x-ray equipment to a new address terminates the certificate of registration at the old address and requires completion of a registration application and payment of registration fees for the new location. Please call our office at (517) 241-1989 to request an application to register at the new location or you may register online. A radiation shielding plan review for the new x-ray room should be submitted (except for those machines limited to intraoral dental x-ray, panoramic machines, bone densitometers, analytical machines, electron microscopes, or security inspection machines).
Information on radiation shielding
is available on this website.
Question: What needs to be done before using an x-ray machine for mammography in the State of Michigan?
Answer: Since all x-ray machines must be registered with the Department of Community Health prior to being put into use, a radiation machine registration application must be completed and returned to the Department with the appropriate registration fee payment. Furthermore, since the intended use of the x-ray machine is for mammography, a mammography machine authorization application must be completed and returned to the Department. Upon receipt and approval of the completed applications and registration fee, the Department will issue a radiation machine registration certificate, radiation machine tag, and mammography authorization to the registrant. In addition to obtaining a registration certificate and mammography authorization from the State of Michigan, the registrant must obtain mammography certification from the U.S. Food and Drug Administration (FDA) by way of making application to the American College of Radiology (ACR) for mammography accreditation. Successful completion of the ACR accreditation application process is necessary for the registrant to maintain both the State of Michigan mammography authorization and FDA mammography certification.
Question: I'm setting up a new x-ray room. What do I need to do to meet the state's radiation shielding requirements?
Answer: The degree of radiation protection for an x‑ray room or other x‑ray enclosure is subject to design approval by the Department's Radiation Safety Section. This approval is based on requirements in Michigan's Ionizing Radiation Rules. The Section reviews the details of submitted building plans and x‑ray room plans, through the Section's formal plan review service, to determine if the proposed radiation shielding for specific x‑ray rooms and areas meets Michigan's radiation safety standards. (One general exception to the need to submit plans is for intra-oral dental x‑ray equipment being using in a clinical, non-training dental office.)
Plans and shielding information should be submitted to the Section as soon as such information is available and in advance of construction whenever possible. The Section may withhold issuing a registration certificate until plans are submitted and approved.
To assist facilities in determining typical shielding requirements for several common types of x‑ray rooms,
information on radiation shielding and room design
is available on this web site. This information may be helpful in proposing shielding for Radiation Safety Section approval.
Information required to be submitted to the Section for a radiation shielding plan review
is also available in PDF format.
Question: My job involves working with x-rays and I'm pregnant. What do I do?
Answer: Notify your employer in writing of your pregnancy. The employer is then responsible for monitoring your radiation dose to ensure it remains below the 500 millirem permissible limit during the gestation period.
Question: I have an old x-ray unit. How do I dispose of it properly?
Answer: X-ray units do not produce any radiation if they are not electrically connected. There is no residual radiation. Disposal is similar to any other electronic appliance. You may want to contact your local x-ray service company for further advice.
Question: What are the minimum requirements for film badges? Why do we need to continue using them if we never see a radiation dose on the badge report?
Answer: Almost every facility that uses x-ray machines must provide personnel dosimeters (film badges or thermoluminescent dosimeters) to employees who use the x-ray equipment. Radiation dose to the dosimeter must be determined at least quarterly. Dental facilities that only have x-ray machines used for intraoral radiographs do not normally need to use film badges, although many voluntarily use them anyway to help ensure that employee radiation doses remain very low. Employers are required to keep radiation doses to their employees below the legal limit of 1250 millirems per calendar quarter, and the dosimeters are the only way to clearly document radiation doses to employees. Therefore, even if no reading occurs on the report (and that is the goal after all!), dosimeter service still must be maintained.
Question: With privacy being a concern, must we list employees birthdates and social security numbers on our radiation dosimetry reports?
Answer: The Ionizing Radiation Rules require, in Rule 245(1), that records showing the radiation doses of all individuals for whom personnel monitoring is required be maintained. Those records must include the name, social security number, and the date of birth of each individual. The obvious reason for this requirement is that an employer, over its history, may have more than one employee with the same name.
However, personal privacy has become a growing concern for our society. It is possible to honor the desire for privacy by maintaining a separate record that would include the individual's social security number, the date of birth, and a unique Employer Assigned Identification Number. This unique number may be provided to the dosimetry provider as an alternative to the social security number.
The facility must maintain in its records the dosimetry reports, provided by the dosimetry provider, and the record that documents the unique, Employer Assigned Identification Number of the employees along with the employee names, dates of birth and social security numbers.
If an employee requests a copy of their dosimetry records, the facility will need to include the Employer Assigned Unique Identification Number, the employee name, social security number, and the date of birth as part of the information that is presented to the employee.
Question: How long do we need to keep our quality assurance/quality control records for mammography?
Answer:
The Ionizing Radiation Rules do not require that these records be kept for a specific length of time. However, the federal Mammography Quality Standards Act (MQSA) does have records retention requirements:
900.12(d)(2): Quality assurance records. The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, and protection employee qualifications to meet assigned quality assurance tasks, are properly maintained and updated. The quality control records shall be kept for each test specified in paragraphs (e) and (f) of this section until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.
The MQSA Policy Guidance Help System (available on
FDA's Mammography Website
), states:
These records must be maintained until the next annual inspection that would verify compliance or until an individual test has been performed two additional times at the required frequency, whichever is longer. Verifying compliance implies that if QC records for a given test were found to be deficient and the facility was cited during an annual inspection, these records must be kept until the facility corrects the problem to FDA's satisfaction. This also means that records for semi-annual tests may have to be kept longer than the period between two successive annual inspections, and records for annual tests must include the most recent two.
While the test result records must be maintained as described above, the actual QC test films need to be retained for only the most recent 30 days. The actual phantom images need to be retained for only the most recent 12 weeks.
A facility may want to keep records longer than what is specified in the MQSA regulations.
If a facility is, as it should be, using the quality assurance/quality control process as a tool to assure good mammography quality, it may be useful to be able to review earlier records: searching for trends, reviewing how similar problems have been corrected in the past, being able to establish how often certain problems reoccur and are then corrected in same manner, noting areas of improvement over the many years, and other reasons not noted here.
The facility should consult with the facility's legal counsel regarding records. It might be beneficial to maintain records which show the quality control status of the mammography facility on any particular day when mammography had been performed.
Question: How long do we have to retain x-ray films?
Answer: Public Act 481 of 2006, which became effective December 22, 2006, specifies the length of time for retention of medical records, including x-ray films. The Act states that medical records and x-ray films must be kept and retained for a minimum of 7 years from the date of service to which the record pertains, unless a longer retention period is required by federal or state laws or regulations.
In the case of mammography films and records, the federal Mammography Quality Standards Act (MQSA) requires films to be retained for:
-
5 years (must be retained for at least 7 years in Michigan)
-
or not less than 10 years if no additional mammograms of the patient are performed.
Question: Who can be a Radiation Protection Supervisor at an x-ray facility, and what are the responsibilities?
Answer: A Radiation Protection Supervisor can be anyone who meets the following criteria as specified in Rule 184(3)
-
Is knowledgeable about the hazards and precautions pertaining to radiation machines.
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Has read and understands the rules.
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Has the authority to make changes which are necessary to comply with the rules.
In addition, Rule 184(3) also specifies generally what the Radiation Protection Supervisor does:
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Permits the operation of the radiation machines only by individuals who have received proper instructions.
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Conducts or arranges for conducting radiation surveys to assure compliance with the rules.
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Establishes operating procedures to assure compliance with the rules.
Additional Radiation Protection Supervisor responsibilities have been specified in other parts of the rules for specific situations.
Question: Do sun-tanning salons and tanning equipment have to be registered and operators licensed?
Answer: See our
Indoor Tanning
page.
Question: Do lasers have to be registered and operators licensed?
Answer: Lasers are not registered by the State of Michigan, and operators of lasers are not licensed.
The State of New Jersey's Radiation Protection Program has information on the
misuse of laser pointers
on their web site.
Question: Whom do I contact regarding radioactive material?
Answer:
The state agency responsible for regulating radioactive material that is not under federal jurisdiction is the
Michigan Department of Environmental Quality
.
The Radiological Protection Section of that division (517-335-2690) monitors naturally occurring and accelerator produced (NARM) radioactive material sources used in medical, educational, industrial and governmental facilities.
Last update: 10/1/2008