OAR 333-123-0040
Quality Assurance And Safety Checks

(1)

Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to 333-123-0025 (Requirements for Therapeutic Radiation Machines) at intervals in accordance with industry standards of practice; and

(a)

Quality assurance checks must include determination of central axis radiation output and a representative sampling of periodic quality assurance checks in accordance with the written procedures established by the Qualified Medical Physicist.

(b)

Quality assurance checks required in this rule must be conducted using a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 333-123-0010 (General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines)(5) of this rule.

(c)

The quality assurance procedures established by the Qualified Medical Physicist must:

(A)

Specify the frequency at which tests or measurements are to be conducted; and

(B)

Specify equipment required for the test; and

(C)

Include the name of personnel conducting the test; and

(D)

Include the acceptable tolerance for each parameter measured in the quality assurance check and the response triggered by test results that exceed tolerance levels.

(d)

The registrant must have the Qualified Medical Physicist review and sign the results of each radiation output quality assurance check within 1 month of the date that the check was performed. The results of each periodic radiation output check must be reviewed according to the following procedures:

(A)

The Radiation Therapy Physician and Qualified Medical Physicist must be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine must not be used clinically until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances; and

(B)

Notwithstanding the other requirements of this rule, the registrant must ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by section (1) of this rule have been performed within the 30 day period immediately prior to said administration.

(2)

Safety Checks. Therapeutic radiation machines subject to 333-123-0025 (Requirements for Therapeutic Radiation Machines) of this rule must have applicable safety quality assurance check in accordance with industry standards of practice and performed at intervals not to exceed 1 week to ensure proper functioning and operation of:

(a)

Electrical interlocks at each external beam radiation therapy room entrance; and

(b)

The “BEAM-ON” and termination switches; and

(c)

Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room; and

(d)

Viewing and auditory systems; and

(e)

If applicable, electrically operated treatment room doors from inside and outside the treatment room; and

(f)

At least one emergency power cutoff switch. If more than one emergency cutoff switch is installed and not all switches are tested at once, each switch must be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the weekly treatment schedule in order to minimize possible stability problems with the therapeutic radiation machine or interruption of patient treatment schedules.

(3)

The registrant must promptly repair any system identified in this rule that is not operating properly.

(4)

The registrant must maintain a record of each quality assurance check required by section (1) of this rule for 3 years. The record must include:

(a)

The date of the quality assurance check;

(b)

The manufacturer’s name, model number, and serial number of the therapeutic radiation machine control panel;

(c)

The record must also include the manufacturer’s name, model number and serial number and calibration date for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and

(d)

The signature of the individual who performed the periodic quality assurance check.

(5)

Quality assurance for a conventional or virtual simulator must include acceptance testing and periodic verification of system performance in accordance with industry standards of practice for a conventional simulator or computed tomography simulators.

Source: Rule 333-123-0040 — Quality Assurance And Safety Checks, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-123-0040.

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 333-123-0040’s source at or​.us