regulatory compliance

I THOUGHT THE DISTRIBUTOR WAS TAKING CARE OF OUR REGISTRATION”

‘THE SALES PERSON SAID ALL WE HAD TO DO WAS PLUG IT IN AND OPERATE, NOTHING ELSE REQUIRED”

“WHY WERE WE NOT TOLD ABOUT THESE EXTRA REQUIREMENTS & COSTS FOR COMPLIANCE & TRAINING WHEN WE PURCHASED THIS EQUIPMENT?”

“NO ONE TOLD US WE HAD TO DO ALL THIS OTHER STUFF”

These comments are heard far too often. Unfortunately, this is a big misconception in this industry. The fact is, it is the OWNERS responsibility to comply with their State or Provincial regulatory requirements, it is NOT the responsibility of the manufacturer, distributor or installer.

Owners often struggle to determine, find and understand what their State or Provincial Radiation Control Agency regulatory requirements are for registering the x-ray equipment, for implementing a written radiation protection program, what are the training requirements, for performing or have performed required x-ray equipment inspections, safety feature testing and radiation surveys of the x-ray equipment. There simply has been nowhere to turn for assistance. Until now!

Many new and existing facility owners of non-medical security and industrial type x-ray inspection machines are rarely informed by the company or salesperson who sold them the radiation machine of their State or Provincial regulatory responsibilities and requirements, therefore; the owner lacks the knowledge, support, guidance, resources and information necessary to achieve and maintain full regulatory compliance after x-ray machine acquisition.

As a result, owners and operators do not know they have to register ALL x-ray equipment, or they must designate an trained and knowledgeable individual responsible for radiation safety on the registration application form (Radiation Safety Officer), or provide operator and radiation safety training, or develop a written Radiation Protection Program, post certain documents, and not to modify the x-ray equipment in any way (e.g., cutting shielded drapes). Many owners are not aware they must perform or have performed inspections, safety interlock testing or radiation surveys and how often. I find regulatory and safety deficiencies in about 75% of the x-ray machines I encounter at facilities I provide training to.

RCE Consulting, LLC can put you on the right path immediately and act as your liaison if we need to contact a State agency.

If you have questions, send an email to contact@rcexraytraining.com or call the Office at 843-650-9724 or Mobile at 865-696-9117 and you will be contacted within 24 hours.

RCE Consulting, LLC offers owners several compliance and training options for any State or Canadian Province and for any budget. Take a look at the Online Courses page to decide which option will best fit your needs. In all cases, you can speak to a real person to discuss your needs once we receive your email request.

FAILURE TO COMPLY WITH STATE OR PROVINCIAL REQUIREMENTS CAN RESULT IN CITATIONS, SUSPENSION AND FINES TO BOTH THE MANUFACTURER, DISTRIBUTOR, INSTALLER AND THE OWNER IF THE VENDOR/ASSEMBLER (WHEN REQUIRED), INSTALLER, FACILITY OR X-RAY EQUIPMENT IS NOT REGISTERED.

The most frequent regulatory violations cited by State or Provincial Inspectors today include:

  • X-Ray System(s) not registered with the State or Provincial Radiation Control Agency
  • No written Radiation Protection Plan and no documented annual review of the RPP
  • No copy of the State regulations or x-ray machine operating manuals on site
  • Not documenting or have documented operator training and not maintaining these records for inspection.
  • Not providing radiation safety training to the x-ray machine operators
  • Not providing radiation monitoring badges, when required (e.g., NV (area monitors only), NJ, NC and SC). Not required in Canada.
  • Not performing x-ray machine safety device testing (E-Stops, safety interlocks and warning indicators)
  • Not performing routine inspections and a radiation leakage emission surveys at the State required minimum ANNUAL frequency. Minimum Annually in Canada.
  • Not using annually calibrated radiation detection instrumentation for radiation surveys.
  • Not informing the State in writing when changes occur that affect the accuracy of the original registration application. Typically within 30 days, some States require before making the change.

Not verifying and obtaining evidence your machine installer is registered as a Vendor / Assembler in the 35 States that require this, see Requirements for Owners & Installers