Regulatory Compliance: Radiation Safety Checklist

Owning and operating radiographic equipment requires compliance with safety rules enforced by the California Department of Public Health (CDPH) and, for those with practices located there, the radiation programs of Los Angeles and San Diego counties. This article summarizes the regulatory requirements for radiation safety.

Machine Registration

Owners of X-ray units must register them with the CDPH. The report or form completed by a vendor or distributor of X-ray equipment is not a registration form. Only the equipment owner may register it. Registration is site specific, so a change of address must be reported if a dental practice moves. Owners may use an online form on the CDPH website to register equipment and to report an address change, removal of equipment, change of ownership and practice closure. Owners are billed registration fees every two years.

Dental practices in Los Angeles and San Diego counties also are required to submit shielding plan review documentation to their respective radiation program.

A portable dental X-ray system cleared by the FDA and used in a manner consistent with that approval may be used in California. The unit should have a backscatter shield that is at least 0.25 mm lead equivalent and permanently affixed. The dental practice that owns and uses such units must have in possession a valid exemption letter from the CDPH (found on the CDPH website).

Regulations also require the machine operator to be behind a protective barrier (lead apron) during each exposure.

Operator Licenses or Certificates

An individual who operates radiographic equipment must have a license from the Dental Board of California and a certificate of completion from a board-approved radiation safety course or a board certificate indicating education equivalent to the boardapproved course.

Posted Notices

“Caution X-rays” signs must be posted where radiographs are taken. “Notice to Employees” (RH-2364) is included in the CDA-provided poster set. If the practice has received a notice or order related to radiological work, it must be posted along with any required response.

Dosimeters/Occupational Exposure Records

Records of occupational exposure to radiation must be kept and be made available to the CDPH upon request. Methods for developing these records include employee use of dosimeters and utilization of a health physicist. An exception to monitoring is allowed when it can be demonstrated that no employee is exposed to more than 10% of the maximum allowable annual dose, which is 5 rems. If the exception is met, monitoring should occur periodically to ensure that exposure does not exceed this amount and as long as no significant exposure is demonstrated or no radiographic equipment is changed.

An individual who uses a portable unit must wear a dosimeter, except for users of devices identified in the CDPH’s exemption letter. A declared pregnant employee who operates X-ray equipment should wear a dosimeter once the employer is notified of the pregnancy.

Written Safety Plan

Dental practices are required to have a written radiation safety program. The document should describe procedures and devices (engineering controls) that dental professionals use to ensure that occupational doses and doses to members of the public are as low as is reasonably achievable (ALARA principle).

A CDA-provided template allows a dental practice to adopt the Radiation Safety Guide into its written program. The guide includes a copy of the state (Title 17) and federal (10 CFR 20) regulations applicable to dental practices. It summarizes standard practices and requirements in the following areas:

■ Responsibilities of the licensed dentist and radiographic machine registrant.

■ Requirements for dental radiographic machines.

■ Patient protection.

■ Responsibilities of dental personnel operating radiographic equipment.

■ Quality assurance and quality control.

■ Equipment quality assurance requirements.

■ Guidelines for prescribing radiographs.

■ Occupationally exposed women of childbearing age.

■ Protective barriers.

Other Required Documentation

Other required documentation includes maintenance records, training documentation and quality assurance records. Maintenance records should note date of maintenance or update and the names of service providers, including those for the electronic image receptor and software. Quality assurance regulations require a dental practice that uses film to have a policy outlining quality assurance processes that include using a reference film each day and maintaining a log of corrective actions. Although the CDPH does not have quality assurance regulations for digital systems, owners of such systems will want to follow the procedures described in ANSI/ADA Standard No. 1094 Quality Assurance for Digital Intra-Oral Radiographic Systems, which was adopted last year.

When an employee informs their employer in writing of their pregnancy, the dentist-employer is required to provide certain information to the employee. The information includes radiation exposure level and risk to the fetus, employer responsibilities and options for protecting the fetus. Such information should be documented. A sample form is available at cda.org/practicesupport.

Inspection

The CDPH and local radiation safety programs inspect radiographic equipment periodically, either onsite or through the use of a screening device mailed to the facility. The inspection program is funded by the X-ray machine registration fees. During the pandemic, dental practices have been offered the option of having a virtual inspection.

An inspection will evaluate compliance with radiation protection laws and regulations. An inspector will take measurements (kVp, timer, exposure and filtration) and evaluate processing procedures. The inspector may make recommendations to correct identified deficiencies and/ or to reduce employee/patient exposure to radiation. Notices of violation may be issued if warranted.

The following documentation must be present at the practice:

■ “Notice to Employees” (included on the CDAprovided poster set and available on the CDPH website.

■ Title 17 and CCR 22 regulations (included in the resource Radiation Safety in Dental Practice available at cda.org/practicesupport).

■ Radiation Safety Instructions (available on cda.org/ practicesupport).

■ Personnel monitoring records or other record of occupational exposure to radiation.

■ Radiation warning signs where machines are used.

■ Exemption letter for handheld portable X-ray systems, if used.

■ Written radiation safety plan (a template is included in the resource Radiation Safety in Dental Practice).

The CDPH also mails to selected dental practices a DIQUAD screening device to inspect X-ray units. After a dental practice exposes and returns the device, the results of the exposure are compared to established standards. Dental practices that return screening devices with the greatest deviation, along with those facilities that did not return the screening devices, are scheduled for on-site inspections. Some practices that return screening devices that are within the normal range also may be selected for on-site inspection.

Machine Disposal

It is difficult to find an entity to which to donate used X-ray equipment, but if successful, dental practices must remember to report to the CDPH the removal of the equipment from inventory. Many dental practices will find themselves having to disassemble a unit for disposal. Ensure parts, especially cooling oil, are disposed properly. Most of the parts can be disposed at the dump with electrical components going to e-waste. Document the disassembly with photos or other documentation and maintain them if asked by inspectors to provide proof of machine’s nonworking status. Unplugging a machine or placing a functional machine in storage for use at another time are not acceptable as proof that the machine is nonfunctional. Report to the CDPH the disposal of the unit and, if applicable, the closure of the dental practice.

Regulatory Compliance appears monthly and features resources about laws that impact dental practices. Visit cda.org/ practicesupport for more than 600 practice support resources, including practice management, employment practices, dental benefit plans and regulatory compliance.