tion, (b) radiation protection, (c) mathematics pertinent to radioactivity, (d)
chemistry of by-product material, and (e) radiation biology and radiation
dosimetry (for radiation safety officer).
The work experience must be under an authorized user, radiation safety
officer, or nuclear pharmacist depending on the specific authorization of by-
product material requested and must include (a) ordering, receiving, and
unpacking radioactive materials, and surveying; (b) calibration of dose
calibrators and survey meters; (c) calculating, measuring, and preparing
dosages for patients; (d) procedures for spill management; (e) safely admin-
istering dosages to patients (for authorized users only); and (f) elution of
radioactive generators (for localization and imaging studies).
In addition, approval by the training and experience method requires a
written certification by a preceptor that the individual has acquired com-
petence in the techniques to function independently for a specified use of
by-product material.
The required hours of training and experience vary for different types of
uses of radioactive material and are listed below.
288 16. Radiation Regulations and Protection
Radiation Safety Officer 200 hrs of classroom and laboratory training in
(10CFR35.50) radiation safety plus 1 yr work experience under a
radiation safety officer
Nuclear Pharmacist (10CFR35.55) 700 hrs of classroom and laboratory training and
supervised work experience in nuclear pharmacy
Authorized User (10CFR35.190) 60 hrs of training and work experience, including
(Uptake, dilution, and excretion) 8 hrs of classroom and laboratory training in
radionuclide handling
Authorized User (10CFR25.290) 700 hrs of training and experience including 80 hrs of
(Localization and imaging) classroom training in basic radionuclide handling
Authorized User (10CFR35.390) 700 hrs of training and work experience, including
(Therapeutic use) 200 hrs of classroom training in basic radionuclide
handling, plus 3 cases in each therapeutic use of
by-product material
Authorized User (10CFR35.392) 80 hrs of classroom and laboratory training in^131 I
(Hyperthyroidism using less than therapy procedures plus 3 cases of hyperthyroid
33 mCi [1.22 GBq]^131 I-NaI) treatments
Authorized User (10CFR35.394) 80 hrs of classroom and laboratory training in^131 I
(Thyroid cancer using greater therapy procedures plus 3 cases of thyroid cancer
than 33 mCi [1.22 GBq]^131 I-NaI) treatments
Report and Notification of a Medical Event
The term medical event has substituted for “misadministration” and
“recordable event” under the revised 10CFR35.3045. A medical event