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Radiation Safety & Nuclear Medicine Compliance Audit

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Compliance audit for nuclear medicine and radioactive materials programs covering the radiation safety officer, ALARA, dose measurement, medical events, and radioactive waste under NRC 10 CFR Part 35.

10 CFR Part 3510 CFR Part 20NRC Materials License42 CFR 482.53

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Program Oversight & Authorization

  • Has the facility designated a qualified Radiation Safety Officer (RSO) named on the NRC or Agreement State license? *
  • Are only authorized users listed on the license permitted to prescribe and administer radiopharmaceuticals? *
  • Does a Radiation Safety Committee review the program where required by license conditions? *

ALARA & Personnel Monitoring

  • Is a documented ALARA (As Low As Reasonably Achievable) program implemented and reviewed? *
  • Are occupational dose limits maintained and personnel dosimetry (badges) issued and monitored for those likely to exceed 10% of limits? *
  • Are area and item surveys performed with calibrated survey instruments and records retained? *

Dosage Determination & Administration

  • Is the activity of each dosage determined by direct measurement or decay calculation before administration? *
  • For applicable therapies, is a written directive completed and signed by an authorized user before administration? *
  • Is patient identity verified by two independent methods before administering the radiopharmaceutical? *

Medical Events & Waste

  • Are medical events (dose errors exceeding regulatory thresholds) identified and reported to the NRC/Agreement State within required timeframes? *
  • Is radioactive waste managed by decay-in-storage or authorized disposal with records retained? *
  • Are sealed sources leak-tested and inventoried at required intervals? *

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