§ 219.3. Definitions.
The following terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Medical reportable event for radiation-producing diagnostic or interventional X-ray procedures—The administration to a human being, except for an administration resulting from a direct intervention of a patient that could not have been reasonably prevented by the licensee or registrant, that results in one of the following:(i) An unintended peak skin dose to the same area in a single procedure greater than 1500 rad (15 Gy).
(ii) An unintended dose, other than skin dose, in a single procedure exceeding five times the facility’s established protocol and 50 rad (0.5 Gy) to any organ.
(iii) A dose to the wrong patient, or wrong site for the entire procedure, and exceeding 50 rad (0.5 Gy) to any organ.
Medical reportable event for radiation-producing machine therapy—The administration to a human being, except for an administration resulting from a direct intervention of a patient that could not have been reasonably prevented by the licensee or registrant, that results in one of the following:(i) An administration of a therapeutic radiation dose to the wrong individual, wrong treatment site or using a treatment delivery intended for another individual.
(ii) An administration of a dose for therapy identified in a written directive that differs from the prescribed dose for the treatment site or any other organ from the intended prescribed dose, by one of the following:
(A) More than 20% of the total prescribed dose.
(B) Exceeds 30% of the weekly prescribed dose.
(C) Exceeds 50% of a single fraction dose of a multifraction plan.
Source The provisions of this § 219.3 adopted November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085; amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial pages (304456) to (304457).
Cross References This section cited in 25 Pa. Code § 228.35 (relating to operating procedures).
No part of the information on this site may be reproduced for profit or sold for profit.
This material has been drawn directly from the official Pennsylvania Code full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
