§ 219.3. Definitions.

 The following term, when used in this subchapter, has the following meaning, unless the context clearly indicates otherwise:

   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.

     (ii)   An administration of a dose for therapy when the result is an increase in the total expected doses inside or outside of the intended treatment volume for organs, tissue or skin that exceeds 20% of the total prescribed dose for the intended target volume.

     (iii)   A total dose delivered to the treatment site identified in a written directive for therapy that is outside the prescribed dose range or differs from the total prescribed dose by more than 20%, or for a fractionated dose, when the weekly administered dose differs from the weekly prescribed dose by more than 30%.

   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. Immediately preceding text appears at serial pages (282368) to (282369).

   This section cited in 25 Pa. Code §  228.35 (relating to operating procedures).