Inspections of X-Ray Machines
What is needed for an X-Ray Inspection?
At the time of the inspection, the inspector will need to contact the Radiation Safety Officer (RSO) or a person with the highest level of management present and available at the facility.
Our inspector will need a staff member that normally operates the x-ray unit(s) available to operate the x-ray unit(s) during an inspection. It takes approximately 10-20 minutes to test each x-ray unit.
Gather the paperwork listed below. Review of paperwork and safety operations may take approximately 60 minutes at most facilities. Larger facilities and hospitals will take longer, depending on the number of x-ray units and the complexity of the inspection.
- Current Certificate of Registration
- Personnel monitoring – records of radiation badge reports - (N/A for dental facilities)
- Dose to the public surveys - (N/A for dental facilities)
- Equipment Performance Evaluations – The last three previous EPE results of each x-ray unit
- Credentials - (N/A for dental and veterinary facilities)
- CT – Status of Radiation Protocol Committee - (N/A for dental and veterinary facilities)
- Fluoroscopy – Status of Radiation Protocol Committee - (N/A for dental and veterinary facilities)
- Posted Notice to Employees
- Operating and Safety Procedures
- A copy of Applicable 25 TAC §289Regulations in accordance with your Certificate of Registration
- Notices of Violation - and your Response Letters to each notice
- Receipt of Purchase – or FDA 2579 Report of Assembly
Transfer or Disposal for all units if applicable
- Annual Evaluation of Protective Devices - (N/A for dental facilities)
- Annual Inventory of X-ray units
- X-ray Image Processing – records of compliance QA/QC for digital acquisition systems or film
X-ray facilities are inspected by DSHS at the following intervals:
CT, Fluoroscopy & Therapy - 2 years
General Purpose – 3 years
Dental & Podiatry – 4 years
Industrial, Service Companies & Veterinary – 5 years
What Do We Inspect?
The Radiation Control Program inspects facilities that use X-rays units and businesses that service X-ray units.
How Long Does an Inspection Take?
A routine inspection involves a review of certain paperwork, testing some of the X-ray units, observation of use activities, and discussions of compliance and/or noncompliance issues. The time will vary based on the number of X-ray units and the type of facility. A small dental or chiropractic office with one or two X-ray units may take about two hours to inspect. A large hospital may take about seven hours to inspect. Inspection times may vary based on the orderliness of recordkeeping and the overall maintenance of X-ray units.
How Often Do We Inspect?
Facilities are normally inspected by the Radiation Control Program on the below intervals. The inspection interval for facilities using multiple types of X-ray units is determined by the types of units with the shortest inspection interval. For example, facilities that use general-purpose and fluoroscopy units would have a two-year interval.
NOTE: With the exception of veterinary facilities, these intervals typically do not coincide with the requirement for facilities to obtain the services of a company to perform their Equipment Performance Evaluation (EPE).
|Type of X-Ray Unit||Inspection Interval|
|General Purpose||3 years|
|Special Purpose||3 years|
How Long Does It Take to Test the X-Ray Units?
It will be necessary to have a credentialed operator who normally operates the X-ray unit(s) available to operate the unit(s) during the inspection. In facilities with a large number of units, the inspector will only test a sample of the units, typically some of each type.
|Type of X-Ray Unit||Approximate Testing Time Per Unit|
|Dental||10-15 minutes -- Intraoral
30-40 minutes -- Panoramic and Cephalometric
|Fluoroscopic||15-20 minutes -- C Arm
30-40 minutes -- R/F Room and Cath Lab
|General Purpose||20-25 minutes|
|Special Purpose||20-25 minutes|
What Records Are Reviewed and How Long Does That Take?
Review of inspection documents will take additional time and will depend on the size and type of the facility. A small dental office or chiropractor will take approximately 45 minutes. A large hospital will take 3-4 hours.
15-30 minutes should be allowed for the inspector to discuss the inspection findings with the radiation safety officer at the conclusion of the inspection.
The inspector may ask to review the following records during the inspection:
- Current Certificate of Registration
- The regulations applicable to your Registration
- Operating and Safety procedures
- Prior Notices of Violations and your reply to these
- Notice to Employees
- Annual evaluations of protective devices and a record of those evaluations
- Equipment Performance Evaluations
- Fluoroscopic machines: annual radiation output measurement performed by a licensed medical physicist
- C.T. machines: annual dose measurements performed by a licensed medical physicist
- Radiation Therapy: surveys and calibrations performed by a licensed medical physicist
- Record of proper credentialing for operators
- Personnel monitoring records
- Dose to the public records
- Records of film processing equipment maintenance.
- QA/QC for digital imaging acquisition systems
- Records of receipt, transfer, and disposal of X-ray machines
- Annual Inventory of all X-ray machines.
- U.S. F.D.A. (Food & Drug Administration) variances for certain X-ray machines
- Radiation Protocol Committee records for Fluoroscopically Guided Interventional (FGI) and/or CT.