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:

1. (i) An unintended peak skin dose to the same area in a single procedure greater than 1500 rad (15 Gy).
2. (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.

3. (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:

4. (i) An administration of a therapeutic radiation dose to the wrong individual, wrong treatment site or using a treatment delivery intended for another individual.

5. (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:

   1. (A) More than 20% of the total prescribed dose.
   2. (B) Exceeds 30% of the weekly prescribed dose.
   3. (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).