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Radioactive
Materials Branch |
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Radioactive
Materials Branch |
| Research (and Development) Laboratory |
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| This category includes licensees perform Research & Development work in biological (in vitro and in vivo), physical and chemical laboratories. Included here are laboratories which use only gas chromatographs.
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| Inspection Frequency* (see notes below) | Varies from 3 - 5 years, depending on the scope and extent of the licensed activities. | |
| Duration of the inspection | 1 hour to 4 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 (for home office inspections), 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, radiation safety procedures, personnel dosimetry records (if applicable), leak tests, physical inventory of sources, 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 | Inspector will observe laboratory personnel performing daily tasks such as setting up experiments, stock vial manipulation, confirmatory 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 violation involving health and safety issues may warrant an increased frequency of inspection.
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INSPECTION FREQUENCY CHART |
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| Laboratories | ||
| In vitro testing only | Every five (5) years | |
| Gas chromatography only | Every five (5) years | |
| Research & Development only (including in vivo testing) | Every five (5) years | |
| License of Broad Scope (click here for broad scope inspection info) | Every three (3) years | |
| Last Modified: 28 October 2016 |
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