RMS - Inspections of Licenses of Broad Scope

Broad License Concept

The agency issues licenses of broad scope to institutions which have a wide and varied use of radioactive materials and the expertise on site to adequately address the health and safety issues associated with that wide and varied use. The hallmark of the license of broad scope is the Radiation Safety Committee (RSC). In effect, the agency turns over some of its regulatory authority to the RSC and allows that body to formulate policies and procedures, enforce those procedures & policies, approve new "users" and "new" radioisotopes, perform safety analyses, etc. The RSC must operate within the bounds of the N.C. Regulations for Protection Against Radiation.

In these institutions, the oversight functions are normally delegated to the Radiation Safety Officer (RSO) and his or her staff. It is their responsibility to ensure that the RSC's policies and procedures and the North Carolina Regulations are being followed by the individual (authorized) users on campus. The RSO & Staff also oversee the receipt, transfer and disposal of all radioactive materials authorized under the license.

Agency inspections of the licenses of broad scope focus on the oversight and enforcement efforts of the Radiation Safety Office. The inspectors examine the interaction between the RSC, RSO and institution Management, as well as the normal duties of the staff.

Academic License of Broad Scope
Inspection Frequency* (see notes below)	Every three (3) years
Duration of the inspection	1 to 5 days, 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, List of protocols approved since last inspection, list of all protocol terminations since the last inspection, authorized user files, Radiation Safety Manual, personnel dosimetry records, records of receipt, transfer, and disposal, records of escalated enforcement actions, copies of the Radioactive Materials License and all subsequent amendments, and other pertinent records which demonstrate compliance with the applicable sections of 10A NCAC 15.
Performance-based component	The inspection team will observe Radiation Safety personnel conduct audits of authorized users, observe daily package receipt procedures, waste pick-ups, response to incidents, and interview laboratory workers and authorized users, etc. The agency's focus during this inspection is to assess the licensee's performance in regulating the use of radioactive materials on campus. The inspection team will make confirmatory measurements and conduct inspections of Authorized User laboratories as well.
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 License of Broad Scope
Inspection Frequency* (see notes below)	Every two (2) years
Duration of the inspection	2 to 5 days, 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 (research & clinical), List of protocols approved since last inspection, list of all protocol terminations, authorized user files, Radiation Safety Manual, personnel dosimetry records, records of receipt and disposal, records of escalated enforcement actions, copies of the Radioactive Materials 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 Radiation Safety personnel conduct audits of authorized users and clinical use areas, observe daily package receipt procedures, waste pick-ups, response to incidents, and interview laboratory workers and authorized users, etc. The agency's focus during this inspection is to assess the licensee's performance in regulating the use of radioactive materials on campus. The inspection team will make confirmatory measurements and conduct inspections of Authorized User laboratories and clinical use areas as well. 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.

Research & Development License of Broad Scope
Inspection Frequency* (see notes below)	Every three (3) years
Duration of the inspection	1 to 5 days, 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, List of protocols approved since last inspection, list of all protocol terminations since the last inspection, records of decommissioning of laboratory/storage areas, authorized user files, Radiation Safety Manual, personnel dosimetry records, records of receipt, transfer, and disposal, records of escalated enforcement actions, copies of the Radioactive Materials License and all subsequent amendments, and other pertinent records which demonstrate compliance with the applicable sections of 10A NCAC 15.
Performance-based component	The inspection team will observe Radiation Safety personnel conduct audits of authorized users, observe daily package receipt procedures, waste pick-ups, response to incidents, and interview laboratory workers and authorized users, etc. The agency's focus during this inspection is to assess the licensee's performance in regulating the use of radioactive materials on campus. The inspection team will make confirmatory measurements and conduct inspections of Authorized User laboratories as well.
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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