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.
Rule 333-123-0040 — Quality Assurance And Safety Checks,