Arizona Radiation Regulatory Agency (ARRA)Medical X-Ray FAQ
1. Do I have to register my x-ray machine?
Yes. You have 30 days after acquisition during which to apply for registration. We are usually notified by the serviceman/installer that a machine is in place through their filing of a FDA 2579 Form, Report of Assembly, with us. They are required to notify us within 15 days after installation. Should you not hear from us soon after the machine is installed, you are still required to register your facility and x-ray machine(s) with ARRA.
2. Are there requirements for a shielding evaluation?
Yes. When you submit your application for registration, you must also submit a floor plan indicating x-ray work area, machine position, amount of lead in the walls, functions on the other side of the walls, etc. Professional health physicists in the community normally perform these shielding evaluations. Their surveys and evaluations are generally accepted for review by the agency. A list of these persons performing shielding evaluations is available on this web site.
3. Is there a fee for using a x-ray machine?
Yes. The first year application fee is: $ 51.00 per tubehead. Each year following the first year, there is an annual fee of $51.00 per tubehead. The fee notice is usually mailed the third week in November and is due by the following January 1st. Failure to pay the annual fee becomes a violation after April 1st. The annual fee helps state government defray the costs associated with registration and inspection.
Inspections are routinely conducted every 3 years. An inspection is not required prior to initial use of the x-ray machine, although an initial inspection is usually conducted within 6 – 7 months of installation. Inspections are unannounced and usually take 30 minutes to an hour. The inspection is based primarily on radiation safety aspects of your operation of the x-ray equipment.
5. Can I teach my employees to take x-rays?
You could, but you would be in violation of the statute. During the course of a radiographic procedure, unlicensed individuals may not perform any of the following acts: position patients or the x-ray tube, set technical factors or initiate the exposure. Uncertified individuals may not perform any of the above tasks while providing assistance with a radiographic procedure. Rule R12-2-101.1. provides:
"Assistance" means any activity except the following: Positioning the patient and x-ray tube, setting techniques, and actual exposure.
Therefore, only persons certified by or exempt (licensed practitioners) from the Medical Radiologic Technologists Board of Examiners Statutes may position the patient, the tube, set technical factors or initiate the exposure for a radiographic exam.
6. Are there maintenance requirements for my x-ray machine?
No. The regulations do not call for a specific preventive maintenance schedule. The Agency recommends, however, that a regular cleaning and calibration schedule for the equipment be established. A simple light field / x-ray field congruency test should be performed by the owner at least once per quarter.
7. How often should my film processor be cleaned?
At least once a month. Many offices do a minimal amount of x-ray work and processing the films becomes an expensive part of the x-ray procedure. Monthly cleaning and changing of the chemistry is important for low and high volume users to maintain film quality.
8. If I use hand tanks, can I extend the life of the chemistry?
No. The developer chemistry oxidizes fairly rapidly whether in an automatic processor or in hand tanks. Again monthly cleaning along with a chemistry change is in order.
9. How many views am I allowed to take?
The Radiation Regulatory Agency does not prescribe the number of views that you can take. Repeat patient exams and number of views should be minimized through careful positioning, good x-ray technique and film processing. However, we do make recommendations on techniques when it is obvious that such things as limiting on-time of the machine could reduce patient exposure. You are always encouraged to use good radiation safety procedures when dealing with patients, personnel and the public.
10. Do I need dosimetry badges?
Not generally in a small practice. Rules require personal dosimetry monitoring if the dose to the individual is likely to exceed 10% of the maximum annual occupational dose limit of 5,000 mRem. We recognize that in some practices, there may be a need to do what is called "comfort badging." This is a possible solution for an employee who is not directly associated with the taking of x-rays, but is concerned about their radiation exposure. The review of records from this type of badging is not required; however, these records should be clearly marked as "not required." Other dosimetry records must be physically on site and available for inspection.
11. Do I need to keep records of correspondence with the Agency?
Yes. By rule a file must be kept which contains all correspondence to and from the Agency. You may be required to show this file during an inspection.
12. Should my registration be posted and, if so, where?
Yes. By rule the Notice of Registration must be posted near the x-ray machine in an area where employees and the public can see the registration. Inspection certificates do not require posting.
13. How long should x-rays be archived?
A good rule is at least until the age of majority for minors and three to seven years for others. We do not regulate this item, but some healthcare certifying organizations make strong recommendations on retention of medical records and x-ray films. In general, the federal Health Insurance Portability and Accountability Act of 1996 (HIPPA) as well as Arizona Revised Statute (12-2297.A) requires keeping them for at least 6 six years. Mammography films have federal retention standards prescribed by the MQSA Statutes.