Current through Register Vol. 54, No.43, October 26, 2024
Section 219.3 - DefinitionsThe 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.The provisions of this §219.3 adopted November 17, 1995, effective 11/18/1995, 25 Pa.B. 5085; amended September 14, 2001, effective 9/15/2001, 31 Pa.B. 5239; amended July 16, 2004, effective 7/17/2004, 34 Pa.B. 3823; amended October 26, 2018, effective 1/24/2019, 48 Pa.B. 6791. This section cited in 25 Pa. Code § 228.35 (relating to operating procedures).