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Radioactive Materials Branch
Inspection Guidance

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Accelerators
 

A Particle Accelerator license authorizes the use and possession of particle accelerators for either industrial, R&D, academic or medical use.  The licensee is required to establish a Radiation Safety Committee (RSC), which has authority over the use of accelerator at the institution.  It is the charge of the RSC to establish and enforce the licensee's policies and procedures and the ensure compliance with the North Carolina Regulations for Protection Against Radiation.  The majority of the regulations for particle accelerators can be found in 10A NCAC 15 .0900.   Additional requirements for Medical Accelerators can be found in 10A NCAC 15 .0609.

 

Academic or Research & Development Accelerator License
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Inspection Frequency* (see notes below) Every five (5) years
Duration of the inspection 2 hours to 1 day, depending on the scope and extent of licensed activities.
Scope of the Inspection Variable.  Scope is determined by taking into account the COMPLIANCE HISTORY as well as issues identified during the current inspection.  The scope and extent of the inspection will be discussed at the entrance meeting, but MAY CHANGE depending on findings during the course of the inspection.
Information that licensee needs to make available at the time of inspection

[Note:   The information presented here is NOT an all-inclusive list.  It is being presented here to give the licensee general guidance on records most frequently audited during an inspection]

Organizational chart, Radiation Safety Committee Minutes, Annual Radiation Protection Program Reviews conducted since last inspection, List of all approved authorized users, personnel dosimetry records, records of shielding designs and surveys, records of escalated enforcement actions, copies of the Accelerator License and all subsequent amendments, and other pertinent records which demonstrate compliance with the applicable sections of 10A NCAC 15.
Performance-based component The inspector observes start-up/shutdown of the accelerator, emergency shutdown, vault entrance, etc.
Who needs to be available for entrance and exit meetings? Preferably, the highest ranking official needs to attend both the entrance and exit meetings.  The agency recognizes that this is not always possible, but the expectation is that an authorized representative of that individual be present at the meetings.

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Medical Accelerator License
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Inspection Frequency* (see notes below) Every five (5) years
Duration of the inspection 2 hours to 1 day, depending on the scope and extent of licensed activities.
Scope of the Inspection Variable.  Scope is determined by taking into account the COMPLIANCE HISTORY as well as issues identified during the inspection process.  The scope and extent of the inspection will be discussed at the entrance meeting, but MAY CHANGE depending on findings during the course of the inspection.
Information that licensee needs to make available at the time of inspection

[Note:   The information presented here is NOT an all-inclusive list.  It is being presented here to give the licensee general guidance on records most frequently audited during an inspection]

Organizational chart, Radiation Safety Committee Minutes, Annual Radiation Protection Program Reviews conducted since last inspection, Quality Management Program Reviews, All misadministrations and/or recordable events, List of all approved authorized users, List of protocols approved since last inspection, list of all protocol terminations, authorized user files, policy/procedure manual, personnel dosimetry records, patient charts, copies of the Accelerator License and all subsequent amendments, and records which demonstrate compliance with the applicable sections of 10A NCAC 15
Performance-based component The inspection team will observe therapists operating the accelerator during patient treatments.  If there is some "down time" the inspector may ask that beam be energized into the treatment room for checking the door interlocks and the radiation levels around the vault.

NOTE:  PATIENT CARE TAKES PRIORITY OVER ANY PART OF THE INSPECTION

Who needs to be available for entrance and exit meetings? Preferably, the highest ranking official needs to attend both the entrance and exit meetings.  The agency recognizes that this is not always possible, but the expectation is that an authorized representative of that individual be present at the meetings.

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NOTES:

*:  Inspection frequency may vary depending upon the licensee's COMPLIANCE HISTORY.  Repeat violations and violation involving health and safety issues may warrant an increased frequency of inspection.

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Last Modified: 27 October 2016
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