Or. Admin. R. 333-123-0045 - Quality Assurance Program

(1) Each registrant or applicant subject to 333-123-0025 must develop, implement, and maintain a quality assurance program to assure that radiation will be administered as directed by the Qualified Radiation Therapy Physician and in a manner that is safe for the patient, the general public, and radiation therapy staff.
(2) The program must include:
(a) Written or Electronic Directives:
(A) A written or electronic directive must be dated and signed by an radiation therapy physician before the administration of radiation; and
(B) If because of the patient's condition, a delay in the order to provide a written or electronic revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient's record and a revised written directive is signed by an authorized user within 48 hours of the oral revision; and
(C) The written directive must contain the patient's full name and patient identification number, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions; and
(D) A written revision to an existing written directive may be made if the revision is dated and signed by a radiation therapy physician before the administration of the external beam dose, or the next fractional dose; and
(E) The registrant must retain copies of written directives for 3 years; and
(F) Any unintended deviation from the written directive must be identified, evaluated and appropriate corrective action taken to prevent recurrence.
(b) The Quality Assurance program must include a process for ensuring that:
(A) Prior to the administration of each course of radiation treatments, the patient's identity is verified by more than one method as the individual named in the written or electronic directive; and
(B) Each administration is in accordance with the written or electronic directive; and
(C) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written or electronic directive; and
(D) Manual or computer generated dose calculations and dose distribution plots are in accordance with the written or electronic directive; and
(E) Monitor units used, are verified and that set-up parameters and machine settings are correctly transferred to the control systems of radiation therapy machines; and
(F) At a minimum, prior to the administration of the first radiation treatment, a Port film or Portal image must be taken to check that the radiation field is properly aligned to the intended treatment area. The Port film or Portal image must be viewed and evaluated and the beam alignment approved by the Radiation Therapy Physician before radiation therapy commences. Thereafter, a weekly Port film or Portal image must be reviewed and signed by a Radiation Therapy Physician.

Notes

Or. Admin. R. 333-123-0045
PH 23-2006, f. & cert. ef. 10-19-06

Stat. Auth: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807

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