RMS - Inspections of Hospital-Based Radioactive Materials Licenses

The agency regulates the use of radioactive materials used in hospitals for both diagnostic and therapeutic uses. 10A NCAC 15 .0300 and .0700 contain regulations which govern these areas. Additionally, there are conditions on the license which must be adhered to. Agency inspections focus on the receipt, use, disposal and storage of radioactive materials and the effectiveness of the Radiation Safety Committee and Radiation Safety Officer (RSO) oversight of the program.

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


Inspection Frequency* (see notes below)	Varies with scope and extent of licensed activities. See table below for additional details
Duration of the inspection	3 hours to 2 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, Annual Radiation Protection Program Reviews conducted since last inspection, Quality Management Program Reviews conducted since last inspection, physicist reports, radiation safety procedures, personnel dosimetry records, QA/QC records, records of misadministrations and/or recordable events (if applicable), records of receipt and disposal, 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	Involves the observation of radioactive materials usage and health physics. Observations of dose administration, surveys, QA/QC of equipment, waste disposal, etc. 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 hospital 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.

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.

INSPECTION FREQUENCY CHART
	Diagnostic Nuclear Medicine (without ablative therapy)	Every three (3) years
	Diagnostic Nuclear Medicine (with ablative therapy)	Every three (3) years
	Brachytherapy (no HDR possession/use)	Every three (3) years
	HDR (with our without associated brachytherapy)	Every two (2) years
	Medical License of Broad Scope	Click here for additional information
	Teletherapy	Every 4 years
	Stereotactic Radiosurgery	Every two (2) years
	In vitro testing only and/or self-shielded irradiator	Every five (5) years
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