Or. Admin. R. 333-116-0715 - Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

Except as provided in OAR 333-116-0740, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

(1) Is an authorized user under OAR 333-116-0680 for uses listed in 333-116-0680(2)(b)(F)(iii) or 333-116-0680(2)(b)(F)(iv) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

(2) Is an authorized user under OAR 333-116-0690 or 333-116-0720, or equivalent U.S. Nuclear Regulatory Commission or Agreement State 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 U.S. Nuclear Regulatory Commission or an Agreement State under OAR 333-116-0690 or 333-116-0720, 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 listed in OAR 333-116-0680(2)(b)(F)(ii).

(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, 333-116-0715, 333-116-0740 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, in the parenteral administrations listed in OAR 333-116-0680(2)(b)(F)(iii). A supervising authorized user who meets the requirements in OAR 333-116-0680, 333-116-0715 or U.S. Nuclear Regulatory Commission or Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. 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 as specified in OAR 333-116-0680(2)(b)(F)(iii); and

(c) Has obtained written attestation that the individual has satisfactorily completed the requirements in section (4) of this rule, and is able to independently fulfill the radiation safety related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation must be obtained from either:

(A) A preceptor authorized user who meets the requirements in OAR 333-116-0680, 333-116-0715, 333-116-0740, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user who meets the requirements in OAR 333-116-0680, 333-116-0715 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or

(B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in OAR 333-116-0680, 333-116-0715, 333-116-0740 or equivalent U.S. Nuclear Regulatory or Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in section (4) and subsection (4)(b) of this rule.

Notes

Or. Admin. R. 333-116-0715

PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14; PH 72-2018, minor correction filed 02/01/2018, effective 2/1/2018; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807