Or. Admin. Code § 333-123-0145

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-123-0145 - Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning

(1) Full calibration, acceptance testing and commissioning must be performed by, or under the direct supervision of a qualified medical physicist.

(2) Acceptance testing and commissioning shall be performed in accordance with industry standards of practice and the manufacturer's specifications. Acceptance testing and commissioning shall be conducted before the first patient treatment following installation or re-installation of the superficial electronic brachytherapy device.

(3) Full calibration must include all applicable parameters in accordance with industry standards of practice and implement all of the manufacturer's specifications to determine that all parameters of the superficial brachytherapy device are within acceptable limits. Full calibration must be completed:

(a) Before the first medical use after installation or reinstallation;

(b) Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent from the value obtained at the last full calibration and the difference cannot be reconciled. Superficial brachytherapy device with multi-energy or multi-mode capabilities must only require measurements for those modes or energies that are not within their acceptable range;

(c) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and energies, measurements must be performed on the effected mode and energy that is in most frequent clinical use at the facility; (d) At intervals not exceeding 12 months, although it shall not be necessary to complete all elements of a full calibration at the same time, all applicable parameters (for all energies) shall be completed.

(4) The registrant must maintain a record of each full calibration for the duration of the registration. The record must include:

(a) The date of the calibration;

(b) The manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the X-ray tube;

(c) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and

(d) The signature of the qualified medical physicist responsible for performing the calibration.

(5) Calibration records must be maintained in accordance with OAR 333-100-0057 for the duration of the registration. The record must include:

(a) The date of the calibration;

(b) The manufacturer's name, model number and serial number for the superficial brachytherapy device;

(c) The model numbers and serial numbers of the instruments used to calibrate the superficial brachytherapy device; and

(d) The signature of the qualified medical physicist responsible for performing or overseeing the calibration.

Or. Admin. Code § 333-123-0145

PH 72-2020, adopt filed 10/09/2020, effective 10/9/2020

Statutory/Other Authority: ORS 453.605 - 453.807

Statutes/Other Implemented: ORS 453.605 - 453.807