Or. Admin. R. 333-123-0110

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-123-0110 - Training

(1) A registrant shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in OAR 333-123-0085. If the interval between patients exceeds one year, retraining of the individuals shall be provided.

(2) In addition to the requirements of OAR 333-123-0015(1) for Radiation Therapy Physicians and OAR 333-123-0015(2) for Qualified Medical Physicists, these individuals shall also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other qualified trainer. The training shall be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of any training protocol recommended by a national professional association, the manufacturer's training protocol shall be followed. The training shall include, but not be limited to:

(a) Device-specific radiation safety requirements;

(b) Device operations;

(c) Clinical use for the types of use approved by the FDA;

(d) Emergency procedures, including an emergency drill; and

(e) The registrant's Quality Assurance Program.

(3) A registrant shall retain a record of individuals receiving instruction required by this rule for three years. The record shall include:

(a) A list of the topics covered;

(b) The date of the instruction;

(c) The name(s) of the attendee(s); and

(d) The name(s) of the individual(s) who provided the instruction.

Or. Admin. R. 333-123-0110

PH 4-2013, f. & cert. ef. 1-29-13

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807