OAR 333-116-0715
Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive
(1)
Is an authorized user under OAR 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required) for uses listed in 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required)(2)(b)(F)(iii) or 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required)(2)(b)(F)(iv) or equivalent Agreement State requirements; or(2)
Is an authorized user under OAR 333-116-0690 (Training for Therapeutic Use of Brachytherapy Source) or 333-116-0720 (Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units), or equivalent Agreement State or Nuclear Regulatory Commission requirements and who meets the requirements in section (4) of this rule; or(3)
Is certified by a medical specialty board whose certification process has been recognized by the Nuclear Regulatory Commission or an Agreement State under OAR 333-116-0690 (Training for Therapeutic Use of Brachytherapy Source) or 333-116-0720 (Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units), and who meets the requirements in section (4) of this rule.(4)
Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, or parenteral administration of any other radionuclide for which a written directive is required.(a)
The training must include:(A)
Radiation physics and instrumentation;(B)
Radiation protection;(C)
Mathematics pertaining to the use and measurement of radioactivity;(D)
Chemistry of byproduct material for medical use; and(E)
Radiation biology; and(b)
Has work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required), 333-116-0715 (Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive), 333-116-0740 (Training for Experienced Authorized User, Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Nuclear Pharmacist or Authorized Nuclear Pharmacist) or equivalent Nuclear Regulatory Commission or Agreement State requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required) must have experience in administering dosages as specified in 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required)(2)(b)(F)(iii) or 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required)(2)(b)(F)(iv). The work experience must involve:(A)
Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;(B)
Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;(C)
Calculating, measuring, and safely preparing patient or human research subject dosages;(D)
Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;(E)
Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and(F)
Administering dosages to patients or human research subjects, that include at least three cases involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV and at least three cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and(c)
Has obtained written attestation that the individual has satisfactorily completed the requirements in sections (2) or (3) of this rule, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in OAR 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required), 333-116-0715 (Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive), 333-116-0740 (Training for Experienced Authorized User, Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Nuclear Pharmacist or Authorized Nuclear Pharmacist) or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required), must have experience in administering dosages as specified in 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required)(2)(b)(F)(iii) or 333-116-0680 (Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required)(2)(b)(F)(iv).
Source:
Rule 333-116-0715 — Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive, https://secure.sos.state.or.us/oard/view.action?ruleNumber=333-116-0715
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