RMS - Inspections of Private Practice Radioactive Materials Licenses

The agency regulates the use of radioactive materials used in the private practice setting 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 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 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, Annual Radiation Protection 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	The inspector observes technologists perform normal day-to-day operations (e.g. receipt of packages, administrations, QA/QC, surveys, 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.

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

INSPECTION FREQUENCY CHART

Diagnostic Nuclear Medicine	Every three (3) years
Brachytherapy (⁹⁰Sr eye applicators, ¹²⁵I/¹⁰³Pd implants)	Every three (3) years
Brachytherapy (with HDR use)	Every two (2) years
Outpatient radiopharmaceutical therapy	Every three (3) years
Veterinary Nuclear Medicine	Every four (4) years
Teletherapy	Every five (5) years
Mobile Nuclear Medicine (field operations)	No set frequency
Mobile Nuclear Medicine (home office)	Every three (3) years
In vitro testing only and/or self-shielded irradiator only	Every five (5) years