Depending on what state you live in, preparing for a dental X-ray machine inspection can be a stressful event. But it doesn’t have to be if you plan properly and make sure you have everything set well in advance of the dreaded day! Every state has different requirements, so check with yours to see what you need to do. However, here are some things that just about every state is looking for that you can have ready to go.
Before the Inspection
For a majority of states, the inspector will notify you in advance of their visit to schedule an appropriate time to come to your practice for the inspection. They will try to be as accommodating as possible with your patient schedule. The inspectors have been trained and instructed to work closely with your staff to minimize patient disruption.
Length of Time for Inspection
How long the inspection takes will depend on the number of dental X-ray machines you have and your patient schedule. Typically, the administrative record review will last 30 minutes. The inspections take approximately 20 minutes per unit. There is also an exit interview that lasts 10-20 minutes. The total time an inspector will be on-site for a facility with three dental X-ray machines is about two and a half to three hours, when you allow for patient accommodation and staff availability.
Required Records for Administrative Review
There are a few records you can have ready to help expedite the inspection process.
- Required postings including Notice-to-Employees and Radiation Safety
- Dental X-ray machine safe operating procedures
- Written radiation safety practices for managing pregnant operators and patients, and prevention of holding patients for dental X-ray exams
- Proof of dental X-ray machine training
- Applicable radiological licenses
- Current certificate of practice registration and/or individual X-ray machine registration
- Equipment inventory such as installations, transfers, and disposals
- Regulations that apply to your facility
- Installation records for each unit, including calibration and/or survey records
- Maintenance records
- Owner operator manuals
- Personnel monitoring reports
- Exposure count
- Area shielding design plans
- Equipment Performance Evaluations
- Evidence of tests run by medical physicists and/or radiation experts
- Any prior violations and corrective actions taken along with follow-up review
- FDA X-ray equipment variances
- Copies of FDA 2579 and state registration forms
- Reports from daily/monthly/quarterly/annually Quality Assurance or Quality Control tests
The Inspection Process
Every dental X-ray machine in your facility will be inspected for the following criteria in each area.
Radiation Safety
The inspector may ensure the physical layout allows the X-ray operator to stand at least six feet away or behind a protective barrier during the exposure time. They may also check to ensure that the exposure stops when the button is released. The inspector may look to see if technique charts are properly displayed as well as availability and storage of patient protective shielding. The dental tube head will be tested for stability and damage, and the cone/collimator will be looked at to ensure it is intact and in place. The beam size will be measured to ensure it doesn’t exceed regulatory requirements. To ensure there is no unnecessary radiation exposure, all adjacent areas may be tested for stray radiation levels. The inspector may also check to see if “Caution Radiation Area” signs are properly displayed and if safety interlocks are in place. Finally, the inspector may check to see if the dental X-ray machine operator can remain in visual contact with the patient during the entire exposure.
Operating Characteristics
The inspector may perform at least four exposures to test each machine. They will ensure kVp accuracy, timer accuracy, and radiation output. All of these variables must be within a 10% range of the selected measurement.
Half Value Layer
When evaluating the half value layer, the inspector will determine if the X-ray beam has been properly filtered and if there is an appropriate amount of aluminum in the useful beam in order to filter out the X-rays that do not provide a diagnostic purpose and are readily absorbed by the patient.
The Exit Interview
Before the inspector leaves, they will likely meet with the appropriate person (doctor, office manager, radiation safety officer) to verbally inform them about the results of the inspection. They will also discuss any errors that were found, if applicable, and provide instruction for correction and further review.
Written Reports
After the inspection is complete, you will typically receive the results via email or mail within 10 business days. This report will describe the focus of the inspection and list any areas that require your attention. Most states allow up to 30 calendar days to complete the updates and provide written proof of their corrections. Once finished, you may receive a statement of compliance.
When you take the time to properly prepare for your dental X-ray machine inspection, it relieves much of the anxiety and stress about that day. Following the above tips will give you a sense of ease when it comes time for your inspection.
