OAR 333-123-0045
Quality Assurance Program

(1)

Each registrant or applicant subject to 333-123-0025 (Requirements for Therapeutic Radiation Machines) 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.

Source: Rule 333-123-0045 — Quality Assurance Program, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-123-0045.

333‑123‑0001
Purpose and Scope 333‑123‑0005
Definitions 333‑123‑0010
General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines 333‑123‑0015
Training and Qualification Requirements for Individuals in the External Beam Radiation Therapy Area 333‑123‑0020
Reports and Notifications of Unplanned Medical Treatment 333‑123‑0025
Requirements for Therapeutic Radiation Machines 333‑123‑0030
Facility Design Requirements for Therapeutic Radiation Machines 333‑123‑0035
Calibration, Acceptance Testing and Commissioning of Therapeutic Radiation Machines 333‑123‑0040
Quality Assurance And Safety Checks 333‑123‑0045
Quality Assurance Program 333‑123‑0050
Qualified Medical Physicist Support in Facilities Having Therapeutic Radiation Machines with Energies of 1 Mv and Above 333‑123‑0055
Electronic Brachytherapy 333‑123‑0060
Facility Design Requirements for Electronic Brachytherapy Devices 333‑123‑0065
Electrical Safety for Electronic Brachytherapy Devices 333‑123‑0070
Control Panel Functions 333‑123‑0075
Timer 333‑123‑0080
Medical Physicist 333‑123‑0085
Operating Procedures 333‑123‑0090
Safety Precautions for Electronic Brachytherapy Devices 333‑123‑0095
Electronic Brachytherapy Source Calibration Measurements 333‑123‑0100
Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices 333‑123‑0105
Therapy Related Computer Systems 333‑123‑0110
Training 333‑123‑0115
Mobile Electronic Brachytherapy Service 333‑123‑0120
Superficial Electronic Brachytherapy 333‑123‑0125
Superficial Electronic Brachytherapy Personnel Requirements 333‑123‑0130
Superficial Electronic Brachytherapy: Refresher Training 333‑123‑0135
Superficial Electronic Brachytherapy: Activation of the Superficial Electronic Brachytherapy X-ray Tube 333‑123‑0140
Superficial Electronic Brachytherapy: Facility Design Requirements 333‑123‑0145
Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning 333‑123‑0150
Superficial Electronic Brachytherapy: Quality Assurance Checks 333‑123‑0155
Superficial Electronic Brachytherapy: Operating Procedures
Last Updated

Jun. 8, 2021

Rule 333-123-0045’s source at or​.us